BIOMERIEUX HEMOLAB COFAC X— 510(k) K935851
Substantially EquivalentBiomerieux Vitek, Inc.
FDA 510(k) clearance K935851 for BIOMERIEUX HEMOLAB COFAC X, Substantially Equivalent on 1995-01-17. Applicant: Biomerieux Vitek, Inc.. Device class: 2.
Clearance details
- Applicant
- Biomerieux Vitek, Inc.
- Product code
- Code GJT
- Device class
- Class 2
- Regulation
- 21 CFR 864.7290
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hazelwood, MO, US
Recent devices under product code GJT
view allMore clearances from Biomerieux Vitek, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.