API-1 STANDARDIZED ANTIMICROBIC SUSCEPTIBILITY SYS
FDA premarket approval P800029/S001 · decided 1981-02-24
Approval details
- PMA number
- P800029
- Supplement
- S001
- Trade name
- API-1 STANDARDIZED ANTIMICROBIC SUSCEPTIBILITY SYS
- Generic name
- SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
- Applicant
- Analytical Products, Inc.
- Date received
- 1981-02-12
- Decision date
- 1981-02-24
- Days to decision
- 12 days
- Decision code
- APPR
- Product code
- LON
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Plainview, NY
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| API 20E/UNISCEPT 20E (K924814) | Analytical Products, Inc. | 1993-03-11 |
| API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC (K923684) | Analytical Products, Inc. | 1992-12-03 |
| API UNISCEPT KB/TYPE 2 AND 3 (K922926) | Analytical Products, Inc. | 1992-10-13 |
| MODIFICATION TO API UNISCEPT 20GP (K901559) | Analytical Products, Inc. | 1990-09-10 |
| DMAC INDOLE REAGENT (K901390) | Analytical Products, Inc. | 1990-04-16 |
| API UNISCEPT KB (K895796) | Analytical Products, Inc. | 1989-11-13 |
| MODIFICATION MIC/API UNISCEPT(R) (K884509) | Analytical Products, Inc. | 1988-11-22 |
| MODIFICATION MICRO-MIC (K884510) | Analytical Products, Inc. | 1988-11-22 |