VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA— 510(k) K923903
Substantially EquivalentBiomerieux Vitek, Inc.
FDA 510(k) clearance K923903 for VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA, Substantially Equivalent on 1993-08-09. Applicant: Biomerieux Vitek, Inc.. Device class: 1.
Clearance details
- Applicant
- Biomerieux Vitek, Inc.
- Product code
- Code LJY
- Device class
- Class 1
- Regulation
- 21 CFR 866.3380
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hazelwood, MO, US
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