← Back to catalogue
Ace Carbon Dioxide(co2-Lc) Reagent, Ace Direct Bilirubin Reagent, Ace Total Bil…
FDA 510(k)Class II (US FDA 510(k))
510(k) K113435
Identifiers
- 510(k) Number
- K113435 FDA 510(k)
- FDA Product Code
- KHS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1160 FDA 510(k)
- Regulation Number
- 862.1160 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Ace Carbon Dioxide(co2-Lc) Reagent, Ace Direct Bilirubin Reagent, Ace Total Bil… by Alfa Wassermann — 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 | K113435 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alfa Wassermann
Sources (1)
- FDA 510(k) K113435 24 fields · synced Jun 18, 2026