VIDAS CREATINE KINASE MB ASSAY 30-421— 510(k) K962549
Substantially EquivalentBiomerieux Vitek, Inc.
FDA 510(k) clearance K962549 for VIDAS CREATINE KINASE MB ASSAY 30-421, Substantially Equivalent on 1996-08-30. Applicant: Biomerieux Vitek, Inc.. Device class: 2.
Clearance details
- Applicant
- Biomerieux Vitek, Inc.
- Product code
- Code JHX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockland, MA, US
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