← Back to catalogue
Axsym Anti-Ccp Reagent, Standard Calibrator And Control Kits (3l91-20 +2 more)
FDA 510(k)Class II (US FDA 510(k))
510(k) K063347
Identifiers
- 510(k) Number
- K063347 FDA 510(k)
- FDA Product Code
- NHX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5775 FDA 510(k)
- Regulation Number
- 866.5775 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Axsym Anti-Ccp Reagent, Standard Calibrator And Control Kits (3l91-20 +2 more) by Axis-Shield Diagnostics, Ltd. — Class II — FDA_510K — listed in FDA 510(k)…
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 | K063347 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Axis-Shield Diagnostics, Ltd.
Sources (1)
- FDA 510(k) K063347 24 fields · synced Jun 19, 2026