Diazyme Laboratories, Inc.
Diazyme Laboratories, Inc. holds FDA 510(k) medical device clearances, first cleared 2018, most recent 2026.
Top product codes for Diazyme Laboratories, Inc.
Recent clearances by Diazyme Laboratories, Inc.
- K253069 — Lipoprotein (a) Molarity Assay
- K252336 — Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay
- K253358 — Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay
- K243462 — Diazyme Colorimetric Lithium Assay
- K211648 — Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
- K220001 — Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
- K212221 — Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer
- K203136 — Diazyme PLAC® Test for Lp-PLA2 Activity
- K180209 — Diazyme 1,5-AG Assay
- K181438 — Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay
- K180074 — Diazyme Lipoprotein (a) Assay
Data sourced from openFDA. This site is unofficial and independent of the FDA.