BIOMERIEUX HEMOLAB FIBRINOMAT— 510(k) K925494
Substantially EquivalentBiomerieux Vitek, Inc.
FDA 510(k) clearance K925494 for BIOMERIEUX HEMOLAB FIBRINOMAT, Substantially Equivalent on 1993-05-18. Applicant: Biomerieux Vitek, Inc.. Device class: 2.
Clearance details
- Applicant
- Biomerieux Vitek, Inc.
- Product code
- Code GIS
- Device class
- Class 2
- Regulation
- 21 CFR 864.7340
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hazelwood, MO, US
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