Company ยท US
Bayer Healthcare, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2018. Name variants (Inc, Corp, punctuation) are merged.
55510(k) clearances (0 in 12 months)
13recalls (0 in 12 months)
10recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 13 |
| LFR | Glucose Dehydrogenase, Glucose | 8 |
| JIX | Calibrator, Multi-Analyte Mixture | 6 |
| NBC | Test, Natriuretic Peptide | 5 |
| DXT | Injector And Syringe, Angiographic | 3 |
| FRN | Pump, Infusion | 3 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 3 |
| GKZ | Counter, Differential Cell | 2 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 2 |
| KQO | Automated Urinalysis System | 2 |
| LCP | Assay, Glycosylated Hemoglobin | 2 |
| MMI | Immunoassay Method, Troponin Subunit | 2 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 2 |
| CDD | Radioassay, Vitamin B12 | 1 |
| CFR | Hexokinase, Glucose | 1 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 1 |
| GKL | Counter, Cell, Automated (Particle Counter) | 1 |
| JFM | Enzymatic Method, Bilirubin | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 7, 2018 | K171802 | ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) Bayer Healthcare, LLC | NUH |
| Dec 22, 2015 | K152852 | ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) Bayer Healthcare, LLC | NUH |
| Nov 25, 2015 | K150942 | Contour Next USB Blood Glucose Monitoring System Bayer Healthcare | NBW |
| Sep 23, 2015 | K151742 | Contour Next Control Solution Bayer Healthcare | JJX |
| Jun 23, 2014 | K130265 | CONTOUR NEXT EZ BLOOD GLUCOSE METER Bayer Healthcare, LLC | NBW |
| Sep 26, 2013 | K122370 | CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR Bayer Healthcare | NBW |
| Jul 26, 2012 | K121190 | CONTOUR NEXT BLOOD GLUCOSE METER Bayer Healthcare, LLC | LFR |
| Jun 28, 2012 | K121087 | CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM Bayer Healthcare | NBW |
| Mar 28, 2012 | K110894 | CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER Bayer Healthcare | LFR |
| Mar 28, 2012 | K110587 | CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW) Bayer Healthcare, LLC | LFR |
| Mar 6, 2012 | K111268 | CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM Bayer Healthcare | LFR |
| Mar 12, 2010 | K093930 | DIDGET WORLD REPORTS Bayer Healthcare, LLC | NBW |
| Dec 4, 2009 | K090628 | DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080 Bayer Healthcare, LLC | NBW |
| Aug 26, 2009 | K091820 | CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM Bayer Healthcare | NBW |
| May 14, 2009 | K090413 | A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC Bayer Healthcare, LLC | LCP |
| Oct 8, 2008 | K082486 | GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE Bayer Healthcare, LLC | NBW |
| Dec 7, 2007 | K063845 | ADVIA CHEMISTRY TOTAL BILIRUBIN_2 Bayer Healthcare, LLC | JFM |
| Dec 28, 2006 | K063276 | CLINITEK ADVANTUS, MODEL 1420 Bayer Healthcare, LLC | JIL |
| Nov 22, 2006 | K062347 | ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM Bayer Healthcare, LLC | NBW |
| Sep 11, 2006 | K062058 | ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080 Bayer Healthcare | NBW |
| Jul 6, 2006 | K061139 | BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS Bayer Healthcare, LLC | JIT |
| Jul 6, 2006 | K061137 | ADVIA IMS CPSA CONTROL Bayer Healthcare, LLC | JJY |
| Apr 12, 2006 | K060470 | ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; ASCENSIA MICROFILL REAGENT STRIP, MODEL 7080 Bayer Healthcare | NBW |
| Dec 30, 2005 | K053020 | TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM Bayer Healthcare, LLC | MMI |
| Dec 14, 2005 | K052503 | TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM Bayer Healthcare, LLC | MMI |
| Dec 7, 2005 | K051693 | MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM Bayer Healthcare, LLC | GKL |
| Oct 11, 2005 | K052163 | ADVIA IMS GLUCOSE ASSAY Bayer Healthcare, LLC | CFR |
| Oct 3, 2005 | K052242 | ADVIA CHEMISTRY MICROALBUMIN CONTROLS Bayer Healthcare, LLC | JJW |
| Aug 1, 2005 | K051619 | LIPOPROTEIN FOR MULTIPLE ANALYTES Bayer Healthcare, LLC | JIX |
| Jun 15, 2005 | K050374 | ADVIA IMS LITHIUM ASSAY Bayer Healthcare, LLC | NDW |
| Jun 13, 2005 | K051265 | ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY Bayer Healthcare, LLC | NBC |
| May 26, 2005 | K050632 | ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY Bayer Healthcare, LLC | LBS |
| Apr 22, 2005 | K043228 | ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS Bayer Healthcare, LLC | NBC |
| Feb 8, 2005 | K042808 | ADVIA IMS CARBAMAZEPINE METHOD Bayer Healthcare, LLC | KLT |
| Feb 8, 2005 | K042807 | ADVIA IMS VALPROIC ACID METHOD Bayer Healthcare, LLC | LEG |
| Dec 22, 2004 | K043311 | ASCENSIA ELITE DIABETES CARE SYSTEM Bayer Healthcare, LLC | NBW |
| Dec 22, 2004 | K043158 | ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM Bayer Healthcare, LLC | NBW |
| Sep 17, 2004 | K042251 | BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM Bayer Healthcare, LLC | GKZ |
| Jul 2, 2004 | K041133 | MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER Bayer Healthcare, LLC | CDD |
| Jun 14, 2004 | K040425 | ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS Bayer Healthcare, LLC | NBC |
| Feb 13, 2004 | K033791 | BAYER SPECIFIC PROTEIN REFERENCE SERUM Bayer Healthcare, LLC | JIX |
| Dec 23, 2003 | K032563 | CLINITEST HCG PREGNANCY TEST Bayer Healthcare, LLC | JHI |
| Dec 19, 2003 | K031947 | BAYER CLINITEK STATUS ANALYZER Bayer Healthcare, LLC | KQO |
| Dec 17, 2003 | K031560 | BAYER RAPIDLAB 1200 SYSTEM Bayer Healthcare, LLC | CHL |
| Sep 9, 2003 | K032525 | BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER Bayer Healthcare, LLC | NBC |
| Sep 8, 2003 | K032524 | ADVIA 60 HEMATOLOGY ANALYZER Bayer Healthcare, LLC | GKZ |
| Aug 6, 2003 | K031683 | TOX AMMONIA CALIBRATOR Bayer Healthcare, LLC | JIX |
| Jun 25, 2003 | K031682 | LIPOPROTEIN CALIBRATOR Bayer Healthcare, LLC | JIX |
| Jun 25, 2003 | K031644 | BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL Bayer Healthcare, LLC | JJY |
| Jun 24, 2003 | K031393 | BAYER ADVIA CENTAUR CA 19-9 ASSAY Bayer Healthcare, LLC | NIG |
Newest 50 of 55.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 11, 2016 | Bayer Healthcare PET Infusion Pump Terminated |
FRN | K080297 K100798 |
| Nov 7, 2016 | Bayer Healthcare MEDRAD Intego PET Infusion System - Pump
Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium Fluoride and commonly used flushing solutions to patients during molecular imaging (nuclea Terminated |
FRN | None listed |
| Aug 2, 2016 | Bayer Healthcare Certegra Workstation used in conjunction with Medrad Stellant CT Injection System
Catalog Number # CWKS DISPLAY
Serial Numbers
The Medrad Stellant CT Injector System is intended for the specific pur Terminated |
DXT | K082905 |
| Jun 9, 2016 | Bayer Healthcare Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit
Usage:
The MEDRAD MRXperion MR Injection System is a syringe based fluid delivery Terminated |
DXT | K143538 |
| Jan 11, 2016 | Bayer Healthcare Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures. Terminated |
FRN | K100798 |
| Sep 16, 2015 | Bayer Healthcare Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of injecting contrast medium and common flushing Terminated |
DXT | K132928 |
| Aug 29, 2015 | Bayer Healthcare, LLC Contour Next Control Solution for Contour Next Blood Glucose Test System.
Liquid quality control solution. Plastic bottle, 2.5mL.
Indicated for use with fresh fingertip capillary whole blood samples Terminated |
JJX | K111268 |
| Nov 2, 2013 | Bayer Healthcare Llc Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated Hemoglobin Assay; Product is manufactured and distributed by
Bayer HealthCare LLC Terminated |
LCP | K090413 |
| Sep 19, 2011 | Bayer Healthcare, LLC Contour, Contour TS Blood Glucose Test Strips and Bonus Packs
Intended for self-testing by people with diabetes and healthcare professionals to monitor glucose concentrations in whole blood Terminated |
LFR | K062058 |
| Mar 13, 2008 | Bayer Healthcare LLC Bayer Contour TS blood glucose test strips packaged in packs of 10, 25, 50 and 100 strips; Bayer Healthcare, Mishawaka, IN. U.S. Product codes 1820, 1823, 1825 and 9578; 1835 and 1836 (Korea); 1832, Terminated |
LFR | None listed |
| Mar 13, 2008 | Bayer Healthcare LLC Bayer Contour TS blood glucose monitoring system with 10 blood glucose test strips enclosed; Bayer Healthcare, Mishawaka, IN. Products 1802 and 1802N (U.S.), 1810 (Korea), 1811 (India, Korea and Mexi Terminated |
LFR | None listed |
| Jul 3, 2007 | Bayer Healthcare LLC Ascensia Contour Blood Glucose Monitoring System ( Bayer )Diabetes Care System; Product 7152A.---NO USA Units are affected---. Terminated |
LFR | K062058 |
| Jul 20, 2004 | Bayer Healthcare LLC Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and 6518C. [The different product codes are for the various countries where the product is distributed). Terminated |
KQO | K960546 |