IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS— 510(k) K910499
Substantially EquivalentVitek Systems, Inc.
FDA 510(k) clearance K910499 for IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS, Substantially Equivalent on 1991-05-01. Applicant: Vitek Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Vitek Systems, Inc.
- Product code
- Code LGC
- Device class
- Class 2
- Regulation
- 21 CFR 866.3305
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockland, MA, US
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