CREATINE KINASE UV REAGENT SET— 510(k) K905588
Substantially EquivalentBiochemical Trade, Inc.
FDA 510(k) clearance K905588 for CREATINE KINASE UV REAGENT SET, Substantially Equivalent on 1991-01-17. Applicant: Biochemical Trade, Inc.. Device class: 2.
Clearance details
- Applicant
- Biochemical Trade, Inc.
- Product code
- Code JHW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
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