HEMOLAB HEPARICHROM ASSAY— 510(k) K934274
Substantially EquivalentBiomerieux Vitek, Inc.
FDA 510(k) clearance K934274 for HEMOLAB HEPARICHROM ASSAY, Substantially Equivalent on 1994-05-06. Applicant: Biomerieux Vitek, Inc.. Device class: 2.
Clearance details
- Applicant
- Biomerieux Vitek, Inc.
- Product code
- Code KFF
- Device class
- Class 2
- Regulation
- 21 CFR 864.7525
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hazelwood, MO, US
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More clearances from Biomerieux Vitek, Inc.
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