REAGENT GOT, ENZYME— 510(k) K770318
Substantially EquivalentIcn Pharmaceuticals, Inc.
FDA 510(k) clearance K770318 for REAGENT GOT, ENZYME, Substantially Equivalent on 1977-04-05. Applicant: Icn Pharmaceuticals, Inc.. Device class: 2.
Clearance details
- Applicant
- Icn Pharmaceuticals, Inc.
- Product code
- Code CIT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1100
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orangeburg, NY, US
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