Data / Medical devices / United States / Diazyme Laboratories, Inc.
Diazyme Laboratories, Inc.: FDA-registered device maker in Poway, CA, United States, 31 510(k) clearances
Diazyme Laboratories, Inc. is registered with the FDA (registration 2032900) in Poway, CA, United States. It lists 39 device types. The FDA files 31 510(k) clearances under its listings, the newest dated June 16, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2032900
- FEI number
- 3004445302
- Address
- 12889 Gregg CT, Poway, CA, United States, 92064
- Owner or operator
- Diazyme Laboratories, Inc. (9057184)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- January 3, 2006
- Registered through
- 2027
- Brand names listed
- 130219015M Diazyme Dz-Lite SARS-CoV-2 IgG CLIA Kit, 130219016M Diazyme DZ-Lite SARS-CoV-2 IgM CLIA Kit, 5'-Nucleotidase Assay, 5'-Nucleotidase Calibrator, 5'-Nucleotidase Control Set, Apolipoprotein A-1 Assay, Apolipoprotein A-1/B Calibrator, Apolipoprotein B Assay and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 16, 2026 | K253069 | Lipoprotein (a) Molarity Assay | DFC | Substantially Equivalent | Diazyme Laboratories, Inc. | accessdata.fda.gov |
| April 13, 2023 | K220763 | ALPCO Calprotectin Immunoturbidimetric Assay | NXO | Substantially Equivalent | ALPCO | accessdata.fda.gov |
| October 4, 2018 | K180209 | Diazyme 1,5-AG Assay | NOZ | Substantially Equivalent | Diazyme Laboratories, Inc. | accessdata.fda.gov |
| June 26, 2018 | K181438 | Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay | DFH | Substantially Equivalent | Diazyme Laboratories, Inc. | accessdata.fda.gov |
| March 22, 2018 | K180074 | Diazyme Lipoprotein (a) Assay | DFC | Substantially Equivalent | Diazyme Laboratories, Inc. | accessdata.fda.gov |
| January 11, 2018 | K172992 | Diazyme EZ Vitamin D Assay | MRG | Substantially Equivalent | Diazyme Laboratories | accessdata.fda.gov |
| April 18, 2017 | K162297 | Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set | PTF | Substantially Equivalent | Diazyme Laboratories | accessdata.fda.gov |
| November 21, 2016 | K160762 | Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set | LCP | Substantially Equivalent | Diazyme Laboratories | accessdata.fda.gov |
| January 31, 2016 | K143470 | Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set | GIS | Substantially Equivalent | Diazyme Laboratories | accessdata.fda.gov |
| December 15, 2014 | K141575 | PLAC TEST FOR LP-PLA2 ACTIVITY | NOE | Substantially Equivalent | Diadexus, Inc. | accessdata.fda.gov |
| June 26, 2013 | K131556 | DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET | JIT | Substantially Equivalent | Diazyme Laboratories | accessdata.fda.gov |
| June 7, 2013 | K123785 | DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET | DDR | Substantially Equivalent | Diazyme Laboratories | accessdata.fda.gov |
| January 24, 2013 | K112120 | DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET | GHH | Substantially Equivalent | Diazyme Laboratories | accessdata.fda.gov |
| June 5, 2012 | K113793 | HOMOCYSTEINE TEST | LPS | Substantially Equivalent | Roche | accessdata.fda.gov |
| December 1, 2011 | K103531 | PRESTIGE 24I; BIOLIS 24I; MGC 240 | CFR | Substantially Equivalent | Tokyo Boeki Medisys, Inc. | accessdata.fda.gov |
| May 17, 2011 | K110188 | DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT | LCP | Substantially Equivalent | Diazyme Laboratories | accessdata.fda.gov |
| April 27, 2011 | K103557 | DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET | DCK | Substantially Equivalent | Diazyme Laboratories | accessdata.fda.gov |
| April 8, 2010 | K093680 | DIAZYME CYSTATIN C ASSAY | NDY | Substantially Equivalent | Diazyme Laboratories | accessdata.fda.gov |
| August 14, 2009 | K091455 | DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL | MZV | Substantially Equivalent | Diazyme Laboratories | accessdata.fda.gov |
| December 5, 2008 | K082001 | DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B | JII | Substantially Equivalent | Diazyme Laboratories | accessdata.fda.gov |
| November 12, 2008 | K082763 | DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B | MZU | Substantially Equivalent | Diazyme Laboratories | accessdata.fda.gov |
| July 16, 2008 | K072977 | DIAZYME APOLIPOPROTEIN A-1 ASSAY | MSJ | Substantially Equivalent | General Atomics | accessdata.fda.gov |
| March 7, 2008 | K073488 | DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX | MSJ | Substantially Equivalent | Diazyme Laboratories | accessdata.fda.gov |
| January 22, 2008 | K072523 | DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS | LBR | Substantially Equivalent | General Atomics | accessdata.fda.gov |
| January 3, 2008 | K072395 | DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS | LBS | Substantially Equivalent | Diazyme Laboratories | accessdata.fda.gov |
| September 17, 2007 | K071971 | DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL | LPS | Substantially Equivalent | Diazyme Laboratories | accessdata.fda.gov |
| April 23, 2007 | K062105 | DIAZYME CREATININE LIQUID REAGENTS ASSAY | JFY | Substantially Equivalent | Diazyme Laboratories | accessdata.fda.gov |
| April 9, 2007 | K070734 | MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON | LCP | Substantially Equivalent | Diazyme Laboratories | accessdata.fda.gov |
| July 21, 2006 | K060619 | DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A | KHS | Substantially Equivalent | Diazyme Laboratories | accessdata.fda.gov |
| December 7, 2005 | K051714 | TOTAL BILE ACIDS ASSAY, MODEL DZ042A | KWW | Substantially Equivalent | Diazyme Laboratories | accessdata.fda.gov |
| October 29, 2004 | K042448 | DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT | JJX | Substantially Equivalent | General Atomics | accessdata.fda.gov |
Compare with other makers
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Updated June 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.