← Back to catalogue
Chromesytems Toxicology Calibrators And Controls
FDA 510(k)Class I (US FDA 510(k))
510(k) K080459
Identifiers
- 510(k) Number
- K080459 FDA 510(k)
- FDA Product Code
- LAS FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3280 FDA 510(k)
- Regulation Number
- 862.3280 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Chromesytems Toxicology Calibrators And Controls by Chromsystems Instruments & Chemicals GmbH — Class I — 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 | K080459 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Chromsystems Instruments & Chemicals GmbH
Sources (1)
- FDA 510(k) K080459 24 fields · synced Jun 19, 2026