EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST— 510(k) K933251
Substantially EquivalentVirion (U.S.), Inc.
FDA 510(k) clearance K933251 for EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST, Substantially Equivalent on 1994-06-13. Applicant: Virion (U.S.), Inc.. Device class: 1.
Clearance details
- Applicant
- Virion (U.S.), Inc.
- Product code
- Code MCD
- Device class
- Class 1
- Regulation
- 21 CFR 866.3235
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morristown, NJ, US
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