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Diazyme Laboratories, Inc.

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories6
Latest FDA decision2026-06-16
TypeNumberDevice NameCodeDateActions
510(k) K253069 Lipoprotein (a) Molarity AssayDFC2026-06-16 View
510(k) K252336 Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay2026-04-24 View
510(k) K253358 Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain AssayDFH2025-12-19 View
510(k) K243462 Diazyme Colorimetric Lithium AssayNDW2025-08-01 View
510(k) K211648 Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDFH2022-09-08 View
510(k) K220001 Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDFH2022-08-04 View
510(k) K212221 Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay AnalyzerDHA2021-12-13 View
510(k) K203136 Diazyme PLAC® Test for Lp-PLA2 ActivityNOE2021-08-06 View
510(k) K180209 Diazyme 1,5-AG AssayNOZ2018-10-04 View
510(k) K181438 Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain AssayDFH2018-06-26 View
510(k) K180074 Diazyme Lipoprotein (a) AssayDFC2018-03-22 View
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