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Diazyme Laboratories, Inc.

11 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Lipoprotein (a) Molarity Assay (K253069)Diazyme Laboratories, Inc.2026-06-16
Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay (K252336)Diazyme Laboratories, Inc.2026-04-24
Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay (K253358)Diazyme Laboratories, Inc.2025-12-19
Diazyme Colorimetric Lithium Assay (K243462)Diazyme Laboratories, Inc.2025-08-01
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay (K211648)Diazyme Laboratories, Inc.2022-09-08
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay (K220001)Diazyme Laboratories, Inc.2022-08-04
Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer (K212221)Diazyme Laboratories, Inc.2021-12-13
Diazyme PLAC® Test for Lp-PLA2 Activity (K203136)Diazyme Laboratories, Inc.2021-08-06
Diazyme 1,5-AG Assay (K180209)Diazyme Laboratories, Inc.2018-10-04
Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay (K181438)Diazyme Laboratories, Inc.2018-06-26
Diazyme Lipoprotein (a) Assay (K180074)Diazyme Laboratories, Inc.2018-03-22

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