Diazyme Laboratories, Inc.
Poway, CA, US
Diazyme Laboratories, Inc. appears in FDA device records in Poway, CA. FDA records list 52 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 52FDA records hold 52 510(k) clearances for Diazyme Laboratories, Inc. between 2003 and 2026. The busiest year on record is 2008, with 5. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2004 | 3 |
| 2005 | 1 |
| 2006 | 3 |
| 2007 | 3 |
| 2008 | 5 |
| 2009 | 1 |
| 2010 | 3 |
| 2011 | 3 |
| 2012 | 4 |
| 2013 | 3 |
| 2014 | 3 |
| 2016 | 5 |
| 2017 | 2 |
| 2018 | 4 |
| 2021 | 2 |
| 2022 | 2 |
| 2025 | 2 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253069 | Lipoprotein (a) Molarity Assay | DFC | Substantially Equivalent | |
| K252336 | Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay | Substantially Equivalent | ||
| K253358 | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay | DFH | Substantially Equivalent | |
| K243462 | Diazyme Colorimetric Lithium Assay | NDW | Substantially Equivalent | |
| K211648 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay | DFH | Substantially Equivalent | |
| K220001 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay | DFH | Substantially Equivalent | |
| K212221 | Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer | DHA | Substantially Equivalent | |
| K203136 | Diazyme PLAC® Test for Lp-PLA2 Activity | NOE | Substantially Equivalent | |
| K180209 | Diazyme 1,5-AG Assay | NOZ | Substantially Equivalent | |
| K181438 | Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay | DFH | Substantially Equivalent | |
| K180074 | Diazyme Lipoprotein (a) Assay | DFC | Substantially Equivalent | |
| K172992 | Diazyme EZ Vitamin D Assay | MRG | Substantially Equivalent | |
| K163418 | Diazyme DZ-Lite Total beta-hCG Test System | DHA | Substantially Equivalent | |
| K162297 | Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set | PTF | Substantially Equivalent | |
| K160762 | Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set | LCP | Substantially Equivalent | |
| K153394 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator | DFH | Substantially Equivalent | |
| K161646 | Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set | CGN | Substantially Equivalent | |
| K161721 | Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set | CDD | Substantially Equivalent | |
| K143470 | Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set | GIS | Substantially Equivalent | |
| K133803 | DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT | LCP | Substantially Equivalent | |
| K133083 | DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET | DBF | Substantially Equivalent | |
| K133410 | DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SET | MRG | Substantially Equivalent | |
| K131556 | DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET | JIT | Substantially Equivalent | |
| K123785 | DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET | DDR | Substantially Equivalent | |
| K112120 | DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET | GHH | Substantially Equivalent | |
| K122420 | DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIA | MRG | Substantially Equivalent | |
| K121558 | DIAZYME HSCRP POC TEST KIT | DCK | Substantially Equivalent | |
| K121053 | DIAZYME HOMOCYSTEINE POC TEST KIT | LPS | Substantially Equivalent | |
| K111664 | DIAZYME CYSTATIN C POC TEST KIT | NDY | Substantially Equivalent | |
| K110188 | DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT | LCP | Substantially Equivalent | |
| K103557 | DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET | DCK | Substantially Equivalent | |
| K102432 | DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL, | MRG | Substantially Equivalent | |
| K102638 | DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS | JIT | Substantially Equivalent | |
| K092911 | SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZER | JJX | Substantially Equivalent | |
| K093680 | DIAZYME CYSTATIN C ASSAY | NDY | Substantially Equivalent | |
| K091455 | DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL | MZV | Substantially Equivalent | |
| K082001 | DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B | JII | Substantially Equivalent | |
| K082763 | DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B | MZU | Substantially Equivalent | |
| K073488 | DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX | MSJ | Substantially Equivalent | |
| K072270 | DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON) | NDY | Substantially Equivalent | |
| K072395 | DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS | LBS | Substantially Equivalent | |
| K071971 | DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL | LPS | Substantially Equivalent | |
| K062105 | DIAZYME CREATININE LIQUID REAGENTS ASSAY | JFY | Substantially Equivalent | |
| K070734 | MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON | LCP | Substantially Equivalent | |
| K060619 | DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A | KHS | Substantially Equivalent | |
| K061296 | DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR | LPS | Substantially Equivalent | |
| K053566 | MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A | MZV | Substantially Equivalent | |
| K051714 | TOTAL BILE ACIDS ASSAY, MODEL DZ042A | KWW | Substantially Equivalent | |
| K042193 | DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT | LCP | Substantially Equivalent | |
| K042191 | DIAZYME POTASSIUM ENZYMATIC ASSAY KIT | MZV | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2032900 | 3004445302 | Diazyme Laboratories, Inc. | 12889 GREGG CT, POWAY, CA 92064 US | 2026 | and 29 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CED5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase
- CGNAcid, Folic, Radioimmunoassay
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- MSJApolipoproteins
- PTFAssay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
- NOZAssay, 1,5-Anhydroglucitol (15ag)
- LCPAssay, Glycosylated Hemoglobin
- NDWAssay, Porphyrin, Spectrophotometry, Lithium
- JIIAtomic Absorption, Lithium
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- JIXCalibrator, Multi-Analyte Mixture
- JITCalibrator, Secondary
- NXOCalprotectin, Fecal
- JFYEnzymatic Method, Creatinine
- KHSEnzymatic, Carbon-Dioxide
- JJTEnzyme Controls (Assayed And Unassayed)
- DBFFerritin, Antigen, Antiserum, Control
- GHHFibrin Split Products
- DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- GFXFibrinogen Standard
- CFRHexokinase, Glucose
- DFHKappa, Antigen, Antiserum, Control
- DEHLambda, Antigen, Antiserum, Control
- LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- LBRLdl & Vldl Precipitation, Hdl
- CHILipase-Esterase, Enzymatic, Photometric, Lipase
- DFCLipoprotein, Low-Density, Antigen, Antiserum, Control
- DDRMyoglobin, Antigen, Antiserum, Control
- JINNitroprusside, Ketones (Urinary, Non-Quant.)
- GILPlasma, Fibrinogen Control
- CDDRadioassay, Vitamin B12
- KWWRadioimmunoassay, Cholyglycine, Bile Acids
- QKOReagent, Coronavirus Serological
- CZSRetinol-Binding Protein, Antigen, Antiserum, Control
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- DHASystem, Test, Human Chorionic Gonadotropin
- LPWSystem, Test, Oxalate
- MZUSystem, Test, Sodium, Enzymatic Method
- MRGSystem, Test, Vitamin D
- NDYTest, Cystatin C
- GISTest, Fibrinogen
- NOETest, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
- MZVTest, System, Potassium, Enzymatic Method
- LPSUrinary Homocystine (Nonquantitative) Test System
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain