Diazyme Laboratories
Medical device manufacturer in Poway, CA.
52510(k) clearances
0PMA approvals
0recalls
Device types
- LCP Assay, Glycosylated Hemoglobin 5
- DFH Kappa, Antigen, Antiserum, Control 5
- LPS Urinary Homocystine (Nonquantitative) Test… 4
- MRG System, Test, Vitamin D 4
- MZV Test, System, Potassium, Enzymatic Method 3
- NDY Test, Cystatin C 3
- MZU System, Test, Sodium, Enzymatic Method 2
- DHA System, Test, Human Chorionic Gonadotropin 2
- DFC Lipoprotein, Low-Density, Antigen… 2
- DCK C-Reactive Protein, Antigen, Antiserum, And… 2
- JIT Calibrator, Secondary 2
- JJX Single (Specified) Analyte Controls… 1
- JII Atomic Absorption, Lithium 1
- NDW Assay, Porphyrin, Spectrophotometry, Lithium 1
- LBS Ldl & Vldl Precipitation, Cholesterol Via… 1
- GHH Fibrin Split Products 1
- JFY Enzymatic Method, Creatinine 1
- DBF Ferritin, Antigen, Antiserum, Control 1
- GIS Test, Fibrinogen 1
- KHS Enzymatic, Carbon-Dioxide 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K253069 | Lipoprotein (a) Molarity AssayDFC · Traditional | 06/16/2026SE |
| K252336 | Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M… · Traditional | 04/24/2026SE |
| K253358 | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light…DFH · Traditional | 12/19/2025SE |
| K243462 | Diazyme Colorimetric Lithium AssayNDW · Traditional | 08/01/2025SE |
| K211648 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDFH · Traditional | 09/08/2022SE |
| K220001 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDFH · Traditional | 08/04/2022SE |
| K212221 | Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800…DHA · Traditional | 12/13/2021SE |
| K203136 | Diazyme PLAC® Test for Lp-PLA2 ActivityNOE · Special | 08/06/2021SE |
| K180209 | Diazyme 1,5-AG AssayNOZ · Traditional | 10/04/2018SE |
| K181438 | Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain AssayDFH · Special | 06/26/2018SE |
| K180074 | Diazyme Lipoprotein (a) AssayDFC · Traditional | 03/22/2018SE |
| K172992 | Diazyme EZ Vitamin D AssayMRG · Traditional | 01/11/2018SE |
| K163418 | Diazyme DZ-Lite Total beta-hCG Test SystemDHA · Traditional | 08/18/2017SE |
| K162297 | Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme…PTF · Traditional | 04/18/2017SE |
| K160762 | Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay…LCP · Traditional | 11/21/2016SE |
| K153394 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay…DFH · Traditional | 11/18/2016SE |
| K161646 | Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control SetCGN · Traditional | 11/04/2016SE |
| K161721 | Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12…CDD · Traditional | 09/20/2016SE |
| K143470 | Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control…GIS · Traditional | 01/31/2016SE |
| K133803 | Diazyme Glycated Serum Protein Poc Test KitLCP · Traditional | 08/06/2014SE |
| K133083 | Diazyme Ferritin Assay, Diazyme Ferritin Calibrator Set, Diazyme Ferritin Control SetDBF · Traditional | 06/24/2014SE |
| K133410 | Diazyme 25-OH Vitamin D Assay; Diazyme 25-OH Vitamin D Control SetMRG · Traditional | 03/14/2014SE |
| K131556 | Diazyme Lipoprotein (a) Calibrator Set, Control SetJIT · Special | 06/26/2013SE |
| K123785 | Diazyme Myoglobin; Assay, Calibrator Set, Control SetDDR · Traditional | 06/07/2013SE |
| K112120 | Diazyme D-Dimer Assay Kit,Calibrator Setand Control SetGHH · Traditional | 01/24/2013SE |
| K122420 | Diazyme 25-HYDROXY Vitamin D Eia Kit Diazyme 25-HYDROXY Vitamin D Eia Control Set DiaMRG · Traditional | 11/28/2012SE |
| K121558 | Diazyme Hscrp Poc Test KitDCK · Traditional | 09/21/2012SE |
| K121053 | Diazyme Homocysteine Poc Test KitLPS · Traditional | 07/31/2012SE |
| K111664 | Diazyme Cystatin C Poc Test KitNDY · Traditional | 03/30/2012SE |
| K110188 | Diazyme Glycated Serum Protein Assay / Calibrator Kit / Control KitLCP · Special | 05/17/2011SE |
| K103557 | Diazyme HS CRP Assay Kit / Calibrator Set / Control SetDCK · Traditional | 04/27/2011SE |
| K102432 | Diazyme 25-HYDROXY Vitamin D Assay Kit Model DZ688A, Diazyme 25-HYDROXY Vitamin D Assay…MRG · Traditional | 01/14/2011SE |
| K102638 | Diazyme Homocysteine Assay Buffer Based CalibratorsJIT · Abbreviated | 11/30/2010SE |
| K092911 | Smart HBA1C Assay Kit, Model DZ168B-POC, Smart HBA1C Assay Control Kit, Model…JJX · Traditional | 04/26/2010SE |
| K093680 | Diazyme Cystatin C AssayNDY · Traditional | 04/08/2010SE |
| K091455 | Diazyme Liquid Stable Enzymatic Potassium Assay Kit, Model DZ113C-X, Diazyme Liquid…MZV · Traditional | 08/14/2009SE |
| K082001 | Diazyme Liquid Stable Enzymatic Lithium Assay, Model DZ116BJII · Special | 12/05/2008SE |
| K082763 | Diazyme Liquid Stable Enzymatic Sodium Assay, Model DZ114BMZU · Special | 11/12/2008SE |
| K073488 | Diazyme Apolipoprotein B Assay, Model Dzxxx-X; B Calibrator, Model DzxxxMSJ · Traditional | 03/07/2008SE |
| K072270 | Diazyme Cystatin C: Assay Kit (DZ133A-K), Calibrator (DZ133A-CAL), Controls (DZ133A-CON)NDY · Traditional | 02/01/2008SE |
| K072395 | Diazyme Hdl-Cholesterol Reagent,Calibrator, ControlsLBS · Traditional | 01/03/2008SE |
| K071971 | Diazyme Homocysteine 2 Reagent Enzymatic Assay Kit, and Calibrators, Model(S) Dzxxxa…LPS · Special | 09/17/2007SE |
| K062105 | Diazyme Creatinine Liquid Reagents AssayJFY · Traditional | 04/23/2007SE |
| K070734 | Modification to: Direct Enzymatic HBA1C Assay Kit, Model# DZ168A, DZ168A-CAL, DZ168A-CONLCP · Special | 04/09/2007SE |
| K060619 | Diazyme Carbon Dioxide Enzymatic Assay Kit, Model KZ122AKHS · Traditional | 07/21/2006SE |
| K061296 | Diazyme Homocysteine Enzymatic Assay Kit for Cobas Integra and Homocysteine CalibratorLPS · Special | 06/13/2006SE |
| K053566 | Modification to: Diazyme Potassium Enzymatic Assay, Model DZ113AMZV · Special | 02/15/2006SE |
| K051714 | Total Bile Acids Assay, Model DZ042AKWW · Traditional | 12/07/2005SE |
| K042193 | Diazyme Glycated Serum Protein Enzymatic Assay KitLCP · Traditional | 10/29/2004SE |
| K042191 | Diazyme Potassium Enzymatic Assay KitMZV · Traditional | 10/29/2004SE |
| K042189 | Diazyme Sodium Enzymatic AssayMZU · Traditional | 10/07/2004SE |
| K032012 | Homocysteine Microtiter Plate AssayLPS · Traditional | 09/03/2003SE |