ENZYME-LINKED FLUORESCENT IMMUNOASSAY— 510(k) K943811
Substantially EquivalentBiomerieux Vitek, Inc.
FDA 510(k) clearance K943811 for ENZYME-LINKED FLUORESCENT IMMUNOASSAY, Substantially Equivalent on 1994-11-02. Applicant: Biomerieux Vitek, Inc.. Device class: 1.
Clearance details
- Applicant
- Biomerieux Vitek, Inc.
- Product code
- Code CFT
- Device class
- Class 1
- Regulation
- 21 CFR 862.1625
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockland, MA, US
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