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VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323 - Vitros Chemistry Products Fs Calibrator 1, Ref 6801873
FDA 510(k)Class I (US FDA 510(k))
510(k) K052645
Identifiers
- 510(k) Number
- K052645 FDA 510(k)
- FDA Product Code
- GTQ FDA 510(k)
- Models / Variants
- Vitros Chemistry Products Fs Calibrator 1, Ref 6801873 FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3720 FDA 510(k)
- Regulation Number
- 866.3720 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323 - Vitros Chemistry Products Fs Calibrator 1, Ref 6801873 by Ortho-Clinical Diagnostics — Class I…
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 | K052645 | Class I | Active |
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Manufacturer
- Manufacturer
- Ortho-Clinical Diagnostics
Sources (1)
- FDA 510(k) K052645 24 fields · synced Jun 18, 2026