← Back to catalogue
Liquichek Tumor Marker Control-Level 1 +3 more models
FDA 510(k)Class I (US FDA 510(k))
510(k) K163015
Identifiers
- 510(k) Number
- K163015 FDA 510(k)
- FDA Product Code
- JJY FDA 510(k)
- Models / Variants
- Liquichek Tumor Marker Control-Level 1 FDA 510(k)Liquichek Tumor Marker Control-Level 2 FDA 510(k)Liquichek Tumor Marker Control-Level 3 FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1660 FDA 510(k)
- Regulation Number
- 862.1660 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Liquichek Tumor Marker Control-Level 1 +3 more models by Bio-Rad Laboratories — Class I — FDA_510K — listed in FDA 510(k) — 4 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 | K163015 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bio-Rad Laboratories
Sources (1)
- FDA 510(k) K163015 24 fields · synced Jun 18, 2026