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..
Clearance details
- Applicant
- Diazyme Laboratories, Inc.
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Poway, CA, US
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