GONODECTEN
FDA premarket approval P770010/S002 · decided 1981-11-19
Approval details
- PMA number
- P770010
- Supplement
- S002
- Trade name
- GONODECTEN
- Generic name
- TEST REAGENTS, NEISSERIA GONORRHOEAE BIOCHEMICAL
- Applicant
- Mediserve International, Inc.
- Date received
- 1981-10-14
- Decision date
- 1981-11-19
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- LTS
- Advisory committee
- Microbiology
- Expedited review
- No
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