EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST
FDA 510(k) clearance K933251 · decided 1994-06-13
Clearance details
- K-number
- K933251
- Device name
- EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST
- Applicant
- Virion (U.S.), Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-07-02
- Decision date
- 1994-06-13
- Days to decision
- 346 days
- Clearance type
- Traditional
- Product code
- MCD
- Device class
- 1
- Regulation number
- 866.3235
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Morristown, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR (K984126) | Zeus Scientific, Inc. | 1999-01-11 |
| MERIDIAN EBV-IGG TEST KIT (K925689) | Fuller Laboratories, Inc. | 1993-10-12 |
| EBV-VCA IGG ELISA TEST SYSTEM (K924091) | Zeus Scientific, Inc. | 1993-01-11 |
| MODIFIED ORTHO EBV VCA-IGG ELISA (K920412) | Ortho Diagnostic Systems, Inc. | 1992-06-22 |
| EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TEST (K911570) | Ortho Diagnostic Systems, Inc. | 1991-06-10 |
| EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST (K911571) | Ortho Diagnostic Systems, Inc. | 1991-06-10 |
| EBV IGG ELISA TEST (K910872) | Gull Laboratories, Inc. | 1991-04-12 |
Recalls involving this device
No recalls on record reference this clearance.