Identifiers
- 510(k) Number
- K252336 FDA 510(k)
- Models / Variants
- Diazyme Immunoglobulin A Assay FDA 510(k)Diazyme Immunoglobulin G Assay FDA 510(k)Diazyme Immunoglobulin M Assay FDA 510(k)
Classification
- Advisory Committee
- Unknown FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Diazyme Immunoglobulin A Assay +2 more models by Diazyme Laboratories, Inc. — FDA_510K — listed in FDA 510(k) — 3 models — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252336 | N/A | Active |
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Manufacturer
- Manufacturer
- Diazyme Laboratories, Inc.
Sources (1)
- FDA 510(k) K252336 24 fields · synced Jun 18, 2026