GONOCOCCAL PILI ANTIBODY TEST
FDA premarket approval P770002 · decided 1979-07-18
Approval details
- PMA number
- P770002
- Trade name
- GONOCOCCAL PILI ANTIBODY TEST
- Generic name
- KIT, IDENTIFICATION, NEISSERIA GONORRHOEAE
- Applicant
- Bioquest
- Date received
- 1977-05-23
- Decision date
- 1979-07-18
- Days to decision
- 786 days
- Decision code
- APWD
- Product code
- JSX
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Cockeysville, MD
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| TAXO DISCS FOR DIFF. OF ANAEROBES (K761209) | Bioquest | 1976-12-09 |
| YEAST ASSIMILATION AGAR (K760764) | Bioquest | 1976-10-29 |