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Diazyme Laboratories

HQ: Poway, CA source · diazyme.com ↗ · West Coast

FDA-cleared device company

Keywords: medical device

Location: Poway, CA · source · Oct 13, 2026

Profile checked Oct 10, 2026

4FDA records (2 yrs)

Timeline

  1. FDA FDA 510(k) clearance: Lipoprotein (a) Molarity Assay — K253069, Jun 16, 2026. Applicant at approval: Diazyme Laboratories, Inc. source ↗
  2. FDA FDA 510(k) clearance: Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay — K252336, Apr 24, 2026. Applicant at approval: Diazyme Laboratories, Inc. source ↗
  3. FDA FDA 510(k) clearance: Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay — K253358, Dec 19, 2025. Applicant at approval: Diazyme Laboratories, Inc. source ↗
  4. FDA FDA 510(k) clearance: Diazyme Colorimetric Lithium Assay — K243462, Aug 1, 2025. Applicant at approval: Diazyme Laboratories, Inc. source ↗

FDA records (last 2 years)

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LinkedIn page linked from the company's own site: source · seen 2026-10-12

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