Company ยท US
Nova Biomedical Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2026. Name variants (Inc, Corp, punctuation) are merged.
129510(k) clearances (2 in 12 months)
41recalls (5 in 12 months)
30recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 39 |
| JGS | Electrode, Ion Specific, Sodium | 23 |
| NBW | System, Test, Blood Glucose, Over The Counter | 16 |
| PZI | Prescription Use Blood Glucose Meter For Near-Patient Testing | 16 |
| CGA | Glucose Oxidase, Glucose | 12 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 8 |
| CGL | Electrode, Ion Based, Enzymatic, Creatinine | 7 |
| JFP | Electrode, Ion Specific, Calcium | 6 |
| CEM | Electrode, Ion Specific, Potassium | 4 |
| GKF | Instrument, Hematocrit, Automated | 3 |
| KHP | Acid, Lactic, Enzymatic Method | 3 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 2 |
| CGZ | Electrode, Ion-Specific, Chloride | 2 |
| GGZ | Oxyhemoglobin | 2 |
| GLY | Oximeter To Measure Hemoglobin | 2 |
| JFL | Ph Rate Measurement, Carbon-Dioxide | 2 |
| JIX | Calibrator, Multi-Analyte Mixture | 2 |
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | 2 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 2 |
| LFR | Glucose Dehydrogenase, Glucose | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 21, 2026 | K251281 | Nova Max Creat eGFR Monitoring System Nova Biomedical Corporation | SHB |
| Jan 9, 2026 | K252206 | Nova Allegro UACR Assay, Nova Allegro Analyzer Nova Biomedical Corporation | CGX |
| Nov 22, 2024 | K221326 | Nova Allegro HbA1c Assay, Nova Allegro Analyzer Nova Biomedical Corporation | LCP |
| Nov 19, 2024 | K221813 | Nova Allegro UACR Assay, Nova Allegro Analyzer Nova Biomedical Corporation | CGX |
| Feb 23, 2024 | K232075 | StatStrip Glucose Hospital Meter System Nova Biomedical Corporation | PZI |
| Sep 29, 2023 | K221900 | Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation | CHL |
| Oct 18, 2022 | K203549 | Nova Primary Glucose Analyzer System Nova Biomedical Corporation | CGA |
| Apr 14, 2020 | K200403 | Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation | JGS |
| Apr 6, 2020 | K200204 | Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation | GGZ |
| Mar 13, 2020 | K200349 | Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation | CGA |
| Jan 24, 2020 | K193246 | Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation | CHL |
| Aug 16, 2019 | K191626 | Stat Profile Prime ES Comp Plus Analyzer System Nova Biomedical Corporation | JFP |
| Jul 19, 2019 | K191365 | Stat Profile Prime ES Comp Plus Analyzer System Nova Biomedical Corporation | JGS |
| Dec 13, 2018 | K182552 | StatStrip Xpress Glucose Hospital Meter System Nova Biomedical Corporation | PZI |
| Dec 13, 2018 | K182549 | StatStrip Xpress 2 Glucose Hospital Meter System Nova Biomedical Corporation | PZI |
| Sep 26, 2018 | K180340 | Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation | CGA |
| Aug 23, 2018 | K180186 | Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation | GGZ |
| Aug 15, 2018 | K180428 | Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation | JGS |
| Jul 17, 2018 | K173797 | Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation | CHL |
| Jul 12, 2018 | K181043 | StatStrip Glucose Hospital Meter System Nova Biomedical Corporation | PZI |
| Nov 7, 2017 | K170464 | StatStrip Xpress Blood Glucose Monitoring System Nova Biomedical Corporation | NBW |
| May 26, 2017 | K171059 | Nova StatSensor Creatinine Hospital Meter System Nova Biomedical Corporation | CGL |
| Apr 11, 2017 | K160990 | Nova Max Uric Acid Monitoring System Nova Biomedical Corporation | PTC |
| Jan 6, 2017 | K163490 | StatStrip Xpress 2 Glucose Hospital Meter System Nova Biomedical Corporation | PZI |
| Nov 15, 2016 | K161856 | StatStrip Xpress Glucose Hospital Meter System Nova Biomedical Corporation | PZI |
| Jun 23, 2016 | K160156 | StatStrip Xpress Blood Glucose Monitoring System Nova Biomedical Corporation | NBW |
| Jan 27, 2016 | K152986 | StatStrip Xpress 2 Glucose Hospital Meter System Nova Biomedical Corporation | PZI |
| Sep 10, 2015 | K151982 | Stat Profile Prime ABG Analyzer System Nova Biomedical Corporation | CHL |
| May 29, 2015 | K141907 | STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG Nova Biomedical Corporation | CHL |
| May 20, 2015 | K150461 | StatStrip Xpress Glucose Hospital Meter System Nova Biomedical Corporation | PZI |
| May 6, 2015 | K150281 | StatStrip Glucose Hospital Meter Nova Biomedical Corporation | PZI |
| Oct 17, 2014 | K142220 | Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators) Nova Biomedical Corporation | CHL |
| Sep 24, 2014 | K132121 | STATSTRIP GLUCOSE HOSPITAL METER SYSTEM Nova Biomedical Corporation | PZI |
| Mar 25, 2014 | K131703 | NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM Nova Biomedical Corporation | CHL |
| Oct 17, 2013 | K131013 | FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM Nova Biomedical Corporation | NBW |
| Apr 4, 2013 | K122688 | NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR Nova Biomedical Corporation | LFR |
| Dec 20, 2012 | K122435 | NOVA ONE BLOOD GLUCOSE MONITOR Nova Biomedical Corporation | LFR |
| Mar 9, 2012 | K112638 | NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS Nova Biomedical Corporation | NBW |
| Jan 5, 2012 | K112955 | NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM Nova Biomedical Corporation | KHP |
| Aug 29, 2011 | K110648 | NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM Nova Biomedical Corporation | CHL |
| Aug 17, 2011 | K100602 | NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS Nova Biomedical Corp. | KHP |
| Aug 27, 2010 | K101633 | NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH Nova Biomedical Corp. | JJY |
| Jan 15, 2010 | K091547 | NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS Nova Biomedical Corp. | NBW |
| Jul 11, 2007 | K070960 | NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM Nova Biomedical Corp. | CGA |
| Jun 13, 2007 | K070255 | NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002 Nova Biomedical Corp. | NBW |
| May 7, 2007 | K070068 | NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS Nova Biomedical Corp. | CGL |
| Jan 24, 2007 | K063821 | NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM Nova Biomedical Corp. | CGA |
| Nov 1, 2006 | K061830 | STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+ Nova Biomedical Corp. | CIG |
| Apr 28, 2006 | K060345 | NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS Nova Biomedical Corp. | CGA |
| May 7, 2004 | K041016 | NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS Nova Biomedical Corp. | JJX |
Newest 50 of 129.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2026 | Nova Biomedical Corporation StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system. Open, Classified |
PZI | None listed |
| Sep 11, 2026 | Nova Biomedical Corporation StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system. Open, Classified |
PZI | None listed |
| Sep 11, 2026 | Nova Biomedical Corporation StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system. Open, Classified |
PZI | None listed |
| Sep 11, 2026 | Nova Biomedical Corporation StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system. Open, Classified |
PZI | K232075 |
| Sep 11, 2026 | Nova Biomedical Corporation StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system. Open, Classified |
PZI | K232075 |
| Dec 20, 2024 | Nova Biomedical Corporation StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-patient testing Open, Classified |
N/A | None listed |
| Dec 20, 2024 | Nova Biomedical Corporation StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient testing Open, Classified |
N/A | None listed |
| Dec 20, 2024 | Nova Biomedical Corporation StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing. Open, Classified |
PZI | K232075 |
| Nov 1, 2023 | Nova Biomedical Corporation Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma.
(1) PN 63368 Stat Profile Prime Plus POC Analyzer
(2) PN 63 Open, Classified |
JGS | K200403 |
| Nov 1, 2023 | Nova Biomedical Corporation Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma.
(1) PN 57400 Stat Profile Prime Plus Analyzer
(2) PN 59508 Stat Pro Open, Classified |
JGS | K200403 |
| Jun 19, 2017 | Nova Biomedical Corporation Nova Biomedical Stat Profile Prime Analyzer as follows:
PN 52855 Stat Profile Prime ABG Analyzer
PN 53655 Stat Profile Prime ABG Analyzer with Scanner
PN 52856 Stat Profile Prime CCS Analyzer
PN 5 Terminated |
CHL | K131703 K141907 +2 |
| Jan 9, 2014 | Nova Biomedical Corporation Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter,
Rechargeable Lithium Batteries
Single: 46626; 4 Pack: Terminated |
CGA | K060345 K063821 +1 |
| Aug 9, 2013 | Nova Biomedical Corporation Nova Max Plus Monitor System (Kit w/10 Count Vials International)
Catalog Number: 45507
Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Terminated |
NBW | K091547 |
| Aug 9, 2013 | Nova Biomedical Corporation Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43861
Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, N Terminated |
NBW | K091547 |
| Aug 9, 2013 | Nova Biomedical Corporation Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877
Product The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Ma Terminated |
NBW | K091547 |
| Aug 9, 2013 | Nova Biomedical Corporation Nova Max Plus Monitor System (Kit w/10 Count Vials)
Catalog Number: 43435
Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Terminated |
NBW | K091547 |
| Aug 9, 2013 | Nova Biomedical Corporation Nova Max Glucose Test Strips (50 Count International
Catalog Number: 45512
Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Ma Terminated |
NBW | K091547 |
| Aug 9, 2013 | Nova Biomedical Corporation Nova Max Glucose Test Strips (10 Count Vials)
Catalog Number: 43604
These strips are kitted into Nova Max Glucose Test Strip System Kits 43435 and 45507
Product Usage: The Nova Max Glucose Test Str Terminated |
NBW | K091547 |
| Aug 9, 2013 | Nova Biomedical Corporation Nova Max Glucose Test Strips (100 Count Retail Canada)Catalog Number: 43955
Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Terminated |
NBW | K091547 |
| Aug 9, 2013 | Nova Biomedical Corporation Nova Max Glucose Test Strips (10 Count Boxed)
Catalog Number: 43590
Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus Terminated |
NBW | K091547 |
| Aug 9, 2013 | Nova Biomedical Corporation Nova Max Glucose Test Strips (50 Count DME)
Catalog Number: 43523
Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Terminated |
NBW | K091547 |
| Aug 9, 2013 | Nova Biomedical Corporation Nova Max Glucose Test Strips (50 Count Retail)
Catalog Number: 43437
Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plu Terminated |
NBW | K091547 |
| Apr 19, 2013 | Nova Biomedical Corporation Nova StatStrip Xpress Glu-Test Strips (Glucose test strips)
Catalog # 51493 (UK Only) Terminated |
CGA | K063821 |
| Apr 19, 2013 | Nova Biomedical Corporation Nova StatStrip Xpress Glu-Test Strips (Glucose test strips)
Catalog # 42214 Terminated |
CGA | K063821 |
| Jun 10, 2010 | Nova Biomedical Corporation Nova StatStrip Glucose Test Strips, Catalog Number: 42214. Nova Biomedical Corporation. Waltham, MA 02454.
Intended for in vitro diagnostic use by health care professionals and for Point-Of-Care us Terminated |
CGA | K060345 K063821 +1 |
| May 7, 2009 | Nova Biomedical Corporation Stat Profile Critical Care Xpress (CCX and CCX+), CCX Creatinine Membrane Kit for CCX analyzer
Catalog # 35238
Intended for in vitro diagnostic use by health care professionals and for point-of-care Terminated |
CGL | K022746 |
| Sep 23, 2008 | Nova Biomedical Corporation Varta Easypack XL Lithium Polymer Batteries (P/N 41772 and 42215)
Used with:
Nova Biomedical StatStrip Glucose Hospital Meter (P/N 42224) and Nova Biomedical StatSensor Creatinine Hospital Meter and Terminated |
CGA | K060345 K070068 |
| Feb 16, 2008 | Nova Biomedical Corporation Nova - EZ CHEM Linearity Solution P/N 9618, Nova Biomedical, Waltham, MA 02454 Terminated |
CGL | K070068 |
| Feb 16, 2008 | Nova Biomedical Corporation Nova - EZ CHEM Control Solution P/N 9612, Nova Biomedical, Waltham, MA 02454 Terminated |
CGL | K070068 |
| Feb 16, 2008 | Nova Biomedical Corporation Nova - EZ CHEM Creatinine Meter: SRS Versions 5.1 and 5.2
P/N 9600, Nova Biomedical, Waltham, MA 02454 Terminated |
CGL | K070068 |
| Jan 17, 2008 | Nova Biomedical Corporation Nova 8 Analyzer Calibrator Pack (Catalog/REF # 15196), Nova Biomedical, Waltham, MA Terminated |
JBS | None listed |
| Feb 28, 2006 | Nova Biomedical Corporation CCX Operating Software , Version 4.08 Terminated |
CHL | None listed |
| Feb 28, 2006 | Nova Biomedical Corporation Stat Profile Critical Care PLUS (CCX) Analyzer
Catalog Number: 37413 Terminated |
CHL | K022746 |
| Feb 28, 2006 | Nova Biomedical Corporation Stat Profile Critical Care (CCX) Analyzer
Catalog Number: 35942 Terminated |
CHL | K020297 |
| Jul 20, 2004 | Nova Biomedical Corporation ABG Replacement Pump Assembly
Catalog Number: 37092 Terminated |
CHL | None listed |
| Jul 20, 2004 | Nova Biomedical Corporation Stat Profile Critical Care Xpress CCX+ (R) Anaylzer
Catalog NUmber: 37555
R= Refurbished Terminated |
CHL | None listed |
| Jul 20, 2004 | Nova Biomedical Corporation Stat Profile Critical Care Xpress CCX (R) Analyzer
Catalog Number: 37562
R= Refurbished Terminated |
CHL | None listed |
| Jul 20, 2004 | Nova Biomedical Corporation Stat Profile Critical Care Xpress CCX+ Analyzer
Catalog Number: 37413 Terminated |
CHL | None listed |
| Jul 20, 2004 | Nova Biomedical Corporation Stat Profile Critical Care Xpress (CCX) Analyzer
Catalog Number: 35942 Terminated |
CHL | K022746 |
| Oct 24, 2003 | Nova Biomedical Corporation Stat Profile Critical Care Expres Ionized Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Critical Care Xpress Analyzer)
Part # 37271 Terminated |
CHL | K022746 |
| Oct 24, 2003 | Nova Biomedical Corporation Stat Profile Ultra Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Ultra M analyzer)
Part # 20394 Terminated |
CHL | K981427 |