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Ace Alkaline Phosphatase Reagent, Ace Amylase Reagent, Ace Ldh-L Reagent
FDA 510(k)Class II (US FDA 510(k))
510(k) K113436
Identifiers
- 510(k) Number
- K113436 FDA 510(k)
- FDA Product Code
- CJE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1050 FDA 510(k)
- Regulation Number
- 862.1050 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Ace Alkaline Phosphatase Reagent, Ace Amylase Reagent, Ace Ldh-L Reagent 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 | K113436 | Class II | Active |
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Manufacturer
- Manufacturer
- Alfa Wassermann
Sources (1)
- FDA 510(k) K113436 24 fields · synced Jun 19, 2026