Chrysalis Intelligence · Sponsors · Diazyme Laboratories, Inc.

Diazyme Laboratories, Inc.

Poway, CA, US · 8 510(k) clearances

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Total clearances
8
2021-08-06 → 2026-06-16
Last 12 months
3
Product codes
6
Most recent
2026-06-16
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
DFH Kappa, Antigen, Antiserum, Control Class II Immunology 3 2025-12-19
DFC — — — 1 2026-06-16
— — — — 1 2026-04-24
NDW Assay, Porphyrin, Spectrophotometry, Lithium Class II Clinical Toxicology 1 2025-08-01
DHA System, Test, Human Chorionic Gonadotropin Class II Clinical Chemistry 1 2021-12-13
NOE Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2 Class II Immunology 1 2021-08-06
Filings

All 510(k) clearances (8)

Date K-number Device Code Class Specialty
2026-06-16 K253069 Lipoprotein (a) Molarity Assay DFC — —
2026-04-24 K252336 Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay — — —
2025-12-19 K253358 Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay DFH Class II Immunology
2025-08-01 K243462 Diazyme Colorimetric Lithium Assay NDW Class II Clinical Toxicology
2022-09-08 K211648 Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay DFH Class II Immunology
2022-08-04 K220001 Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay DFH Class II Immunology
2021-12-13 K212221 Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer DHA Class II Clinical Chemistry
2021-08-06 K203136 Diazyme PLAC® Test for Lp-PLA2 Activity NOE Class II Immunology
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence