Company · US
Diazyme Laboratories
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2026. Name variants (Inc, Corp, punctuation) are merged.
52510(k) clearances (3 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DFH | Kappa, Antigen, Antiserum, Control | 5 |
| LCP | Assay, Glycosylated Hemoglobin | 5 |
| LPS | Urinary Homocystine (Nonquantitative) Test System | 4 |
| MRG | System, Test, Vitamin D | 4 |
| MZV | Test, System, Potassium, Enzymatic Method | 3 |
| NDY | Test, Cystatin C | 3 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 2 |
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | 2 |
| DHA | System, Test, Human Chorionic Gonadotropin | 2 |
| JIT | Calibrator, Secondary | 2 |
| MZU | System, Test, Sodium, Enzymatic Method | 2 |
| CDD | Radioassay, Vitamin B12 | 1 |
| CGN | Acid, Folic, Radioimmunoassay | 1 |
| DBF | Ferritin, Antigen, Antiserum, Control | 1 |
| DDR | Myoglobin, Antigen, Antiserum, Control | 1 |
| GHH | Fibrin Split Products | 1 |
| GIS | Test, Fibrinogen | 1 |
| JFY | Enzymatic Method, Creatinine | 1 |
| JII | Atomic Absorption, Lithium | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 16, 2026 | K253069 | Lipoprotein (a) Molarity Assay Diazyme Laboratories, Inc. | DFC |
| Apr 24, 2026 | K252336 | Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay Diazyme Laboratories, Inc. | |
| Dec 19, 2025 | K253358 | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay Diazyme Laboratories, Inc. | DFH |
| Aug 1, 2025 | K243462 | Diazyme Colorimetric Lithium Assay Diazyme Laboratories, Inc. | NDW |
| Sep 8, 2022 | K211648 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay Diazyme Laboratories, Inc. | DFH |
| Aug 4, 2022 | K220001 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay Diazyme Laboratories, Inc. | DFH |
| Dec 13, 2021 | K212221 | Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer Diazyme Laboratories, Inc. | DHA |
| Aug 6, 2021 | K203136 | Diazyme PLAC® Test for Lp-PLA2 Activity Diazyme Laboratories, Inc. | NOE |
| Oct 4, 2018 | K180209 | Diazyme 1,5-AG Assay Diazyme Laboratories, Inc. | NOZ |
| Jun 26, 2018 | K181438 | Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay Diazyme Laboratories, Inc. | DFH |
| Mar 22, 2018 | K180074 | Diazyme Lipoprotein (a) Assay Diazyme Laboratories, Inc. | DFC |
| Jan 11, 2018 | K172992 | Diazyme EZ Vitamin D Assay Diazyme Laboratories | MRG |
| Aug 18, 2017 | K163418 | Diazyme DZ-Lite Total beta-hCG Test System Diazyme Laboratories | DHA |
| Apr 18, 2017 | K162297 | Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set Diazyme Laboratories | PTF |
| Nov 21, 2016 | K160762 | Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Diazyme Laboratories | LCP |
| Nov 18, 2016 | K153394 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Diazyme Laboratories | DFH |
| Nov 4, 2016 | K161646 | Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set Diazyme Laboratories | CGN |
| Sep 20, 2016 | K161721 | Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set Diazyme Laboratories | CDD |
| Jan 31, 2016 | K143470 | Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set Diazyme Laboratories | GIS |
| Aug 6, 2014 | K133803 | DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT Diazyme Laboratories | LCP |
| Jun 24, 2014 | K133083 | DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET Diazyme Laboratories | DBF |
| Mar 14, 2014 | K133410 | DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SET Diazyme Laboratories | MRG |
| Jun 26, 2013 | K131556 | DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET Diazyme Laboratories | JIT |
| Jun 7, 2013 | K123785 | DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET Diazyme Laboratories | DDR |
| Jan 24, 2013 | K112120 | DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET Diazyme Laboratories | GHH |
| Nov 28, 2012 | K122420 | DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIA Diazyme Laboratories | MRG |
| Sep 21, 2012 | K121558 | DIAZYME HSCRP POC TEST KIT Diazyme Laboratories | DCK |
| Jul 31, 2012 | K121053 | DIAZYME HOMOCYSTEINE POC TEST KIT Diazyme Laboratories | LPS |
| Mar 30, 2012 | K111664 | DIAZYME CYSTATIN C POC TEST KIT Diazyme Laboratories | NDY |
| May 17, 2011 | K110188 | DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT Diazyme Laboratories | LCP |
| Apr 27, 2011 | K103557 | DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET Diazyme Laboratories | DCK |
| Jan 14, 2011 | K102432 | DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL, Diazyme Laboratories | MRG |
| Nov 30, 2010 | K102638 | DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS Diazyme Laboratories | JIT |
| Apr 26, 2010 | K092911 | SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZER Diazyme Laboratories | JJX |
| Apr 8, 2010 | K093680 | DIAZYME CYSTATIN C ASSAY Diazyme Laboratories | NDY |
| Aug 14, 2009 | K091455 | DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL Diazyme Laboratories | MZV |
| Dec 5, 2008 | K082001 | DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B Diazyme Laboratories | JII |
| Nov 12, 2008 | K082763 | DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B Diazyme Laboratories | MZU |
| Mar 7, 2008 | K073488 | DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX Diazyme Laboratories | MSJ |
| Feb 1, 2008 | K072270 | DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON) Diazyme Laboratories | NDY |
| Jan 3, 2008 | K072395 | DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS Diazyme Laboratories | LBS |
| Sep 17, 2007 | K071971 | DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL Diazyme Laboratories | LPS |
| Apr 23, 2007 | K062105 | DIAZYME CREATININE LIQUID REAGENTS ASSAY Diazyme Laboratories | JFY |
| Apr 9, 2007 | K070734 | MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON Diazyme Laboratories | LCP |
| Jul 21, 2006 | K060619 | DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A Diazyme Laboratories | KHS |
| Jun 13, 2006 | K061296 | DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR Diazyme Laboratories | LPS |
| Feb 15, 2006 | K053566 | MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A Diazyme Laboratories | MZV |
| Dec 7, 2005 | K051714 | TOTAL BILE ACIDS ASSAY, MODEL DZ042A Diazyme Laboratories | KWW |
| Oct 29, 2004 | K042193 | DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT Diazyme Laboratories | LCP |
| Oct 29, 2004 | K042191 | DIAZYME POTASSIUM ENZYMATIC ASSAY KIT Diazyme Laboratories | MZV |
Newest 50 of 52.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||