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AXSYM HOLO TC REAGENT KIT - Control Kit, Model 3l83-10
FDA 510(k)Class II (US FDA 510(k))
510(k) K062467
Identifiers
- 510(k) Number
- K062467 FDA 510(k)
- FDA Product Code
- CDD FDA 510(k)
- Models / Variants
- Axsym Holo Tc Reagent Kit, Model 3l83-20 FDA 510(k)Standard Calibrator Kit, Model 3l83-01 FDA 510(k)Control Kit, Model 3l83-10 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1810 FDA 510(k)
- Regulation Number
- 862.1810 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
AXSYM HOLO TC REAGENT KIT - Control Kit, Model 3l83-10 by Axis-Shield Diagnostics, Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 3 models
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 | K062467 | Class II | Active |
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Manufacturer
- Manufacturer
- Axis-Shield Diagnostics, Ltd.
Sources (1)
- FDA 510(k) K062467 24 fields · synced Jun 18, 2026