Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay— 510(k) K252336
Substantially EquivalentDiazyme Laboratories, Inc.
FDA 510(k) clearance K252336 for Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay, Substantially Equivalent on 2026-04-24. Applicant: Diazyme Laboratories, Inc..
Summary
Diazyme Laboratories' record names three assays: the Diazyme Immunoglobulin A Assay, Diazyme Immunoglobulin G Assay, and Diazyme Immunoglobulin M Assay. The record gives no product code for them.
The record gives no device class or regulation number. The classification panel is listed as Unknown, and the Immunology review panel handled it as a Traditional 510(k).
Diazyme Laboratories filed from Poway, California. The record shows 270 calendar days from receipt to decision (July 28, 2025 to April 24, 2026).
Clearance details
- Applicant
- Diazyme Laboratories, Inc.
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Poway, CA, US
More clearances from Diazyme Laboratories, Inc.
view all- K253069 — Lipoprotein (a) Molarity 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.