VIROGEN CMV ANTIBODY TEST
FDA 510(k) clearance K875101 · decided 1988-03-01
Clearance details
- K-number
- K875101
- Device name
- VIROGEN CMV ANTIBODY TEST
- Applicant
- Wampole Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1987-12-10
- Decision date
- 1988-03-01
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- LQO
- Device class
- 1
- Regulation number
- 866.3110
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cranbury, 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 |
|---|---|---|
| ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATION (K894712) | Gen-Probe, Inc. | 1989-11-14 |
| SNAP CAMPYLOBACTOR DIAGNOSTIC KIT (K873670) | Molecular Biosystems, Inc. | 1988-06-08 |
| GENE-TRAK CAMPYLOBACTER ASSAY (K863270) | Integrated Genetics | 1987-08-31 |
Recalls involving this device
No recalls on record reference this clearance.