GONOSTICON DRI-DOT
FDA premarket approval N17985/S001 · decided 1981-04-14
Approval details
- PMA number
- N17985
- Supplement
- S001
- Trade name
- GONOSTICON DRI-DOT
- Generic name
- KIT, IDENTIFICATION, NEISSERIA GONORRHOEAE
- Applicant
- Organon, Inc.
- Date received
- 1981-02-23
- Decision date
- 1981-04-14
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- JSX
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- El Monte, CA
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| RECONSTITUTION ACCESSOREIS (K950861) | Organon, Inc. | 1995-05-26 |
| MONOSTICON UNI-DOT (K853388) | Organon, Inc. | 1985-08-22 |
| DUOCLON COLOR-CEPT (K842314) | Organon, Inc. | 1984-08-24 |
| OREIA II B-HCG PREGNANCY TEST KIT (K841525) | Organon, Inc. | 1984-06-05 |
| ACCURATE BETA 30 PREGNANCY TEST KIT (K841602) | Organon, Inc. | 1984-05-22 |
| B-NEOCEPT 30 (K840650) | Organon, Inc. | 1984-04-04 |
| OREIA II B-HCG, ENZYME INNUNOASSAY (K832801) | Organon, Inc. | 1983-12-08 |
| NEO-PREGNOSTICON DUOCLON TUBE TEST (K831339) | Organon, Inc. | 1983-06-08 |