Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay

FDA 510(k) K252336 · Diazyme Laboratories, Inc.

Substantially Equivalent

510(k) numberK252336

Submission

Device name: Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay
Applicant: Diazyme Laboratories, Inc.
Poway, CA, US
Received: July 28, 2025
Decision date: April 24, 2026
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

No product code recorded.

More from Diazyme Laboratories, Inc.

510(k)	Device	Decision
K253069	Lipoprotein (a) Molarity AssayDFC · Traditional	06/16/2026SE
K253358	Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light…DFH · Traditional	12/19/2025SE
K243462	Diazyme Colorimetric Lithium AssayNDW · Traditional	08/01/2025SE
K211648	Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDFH · Traditional	09/08/2022SE
K220001	Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDFH · Traditional	08/04/2022SE
K212221	Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800…DHA · Traditional	12/13/2021SE
K203136	Diazyme PLAC® Test for Lp-PLA2 ActivityNOE · Special	08/06/2021SE
K180209	Diazyme 1,5-AG AssayNOZ · Traditional	10/04/2018SE
K181438	Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain AssayDFH · Special	06/26/2018SE
K180074	Diazyme Lipoprotein (a) AssayDFC · Traditional	03/22/2018SE

Questions and answers

When was Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay cleared by the FDA?

Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay (K252336) received a 510(k) decision of Substantially Equivalent on April 24, 2026, 270 days after the submission was received.