# Diazyme Laboratories

- Location (FDA's records): Poway, CA
- FDA decisions: 52 (2003–2026): 52 510(k) clearances
- Names in FDA's records: Diazyme Laboratories (41); Diazyme Laboratories, Inc. (11)
- Product codes: DFH (5), LCP (5), MRG (4), LPS (4), NDY (3), MZV (3), DCK (2), JIT (2), DHA (2), MZU (2), DFC (2), NOZ (1)
- 510(k) review time since 2016: median 181 days, against 315 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 33 (9 its own); citations of its devices by later devices: 15 (9 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Roche Diagnostics Corp.: 4 (https://510kreport.com/company/roche-diagnostics)
- The Binding Site, Ltd.: 3 (https://510kreport.com/company/binding-site)
- DiaSorin, Inc.: 2 (https://510kreport.com/company/diasorin)
- Kamiya Biomedical Co.: 2 (https://510kreport.com/company/kamiya-biomedical)
- Beckman Coulter, Inc.: 2 (https://510kreport.com/company/beckman-coulter)
- Immunodiagnostic Systems, Ltd.: 2 (https://510kreport.com/company/immunodiagnostic-systems)
- Tomen America, Inc.: 1 (https://510kreport.com/company/tomen-america)
- General Atomics: 1 (https://510kreport.com/company/general-atomics)

## Firms that cite its devices most
- Roche: 2 (https://510kreport.com/company/roche)
- Ortho-Clinical Diagnostics, Inc.: 1 (https://510kreport.com/company/ortho-clinical-diagnostics)
- SENTINEL CH. SpA: 1 (https://510kreport.com/company/sentinel-ch)
- Roche Diagnostics Corp.: 1 (https://510kreport.com/company/roche-diagnostics)
- Siemens Healthcare Diagnostics, Inc.: 1 (https://510kreport.com/company/siemens-healthcare-diagnostics)

## Its most-cited devices
- K093680: Diazyme Cystatin C Assay (2010), cited by 2
- K070734: Modification to: Direct Enzymatic HBA1C Assay Kit, Model# DZ168A, DZ168A-Cal, DZ168A-Con (2007), cited by 2
- K071971: Diazyme Homocysteine 2 Reagent Enzymatic Assay Kit, and Calibrators, Model (S) Dzxxxa, Dzxxxa-Cal (2007), cited by 2
- K103557: Diazyme HS CRP Assay Kit / Calibrator Set / Control Set (2011), cited by 2
- K180074: Diazyme Lipoprotein (a) Assay (2018), cited by 2
- K110188: Diazyme Glycated Serum Protein Assay / Calibrator Kit / Control Kit (2011), cited by 1

## Recent decisions
- K253069: Lipoprotein (a) Molarity Assay (Jun 16, 2026)
- K252336: Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay (Apr 24, 2026)
- K253358: Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay (Dec 19, 2025)
- K243462: Diazyme Colorimetric Lithium Assay (Aug 1, 2025)
- K211648: Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay (Sep 8, 2022)
- K220001: Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay (Aug 4, 2022)
- K212221: Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer (Dec 13, 2021)
- K203136: Diazyme PLAC® Test for Lp-PLA2 Activity (Aug 6, 2021)

Source page: https://510kreport.com/company/diazyme-laboratories