UTI MIC TEST PANEL
FDA premarket approval N50487/S007 · decided 1981-05-06
Approval details
- PMA number
- N50487
- Supplement
- S007
- Trade name
- UTI MIC TEST PANEL
- Generic name
- SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
- Applicant
- Microtech Medical Systems, Inc.
- Date received
- 1980-12-16
- Decision date
- 1981-05-06
- Days to decision
- 141 days
- Decision code
- APPR
- Product code
- LON
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Potomic, MD
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| FAS FASTIDIOUS MIC PANEL (K935485) | Microtech Medical Systems, Inc. | 1995-02-16 |
| FASTIDIOUS MIC PANEL (K901598) | Microtech Medical Systems, Inc. | 1990-11-08 |
| SUPPLEMENT TO ANAEROBIC MIC PANEL (K896332) | Microtech Medical Systems, Inc. | 1990-02-05 |
| ANAEROBIC MIC PANEL (K884831) | Microtech Medical Systems, Inc. | 1989-03-27 |
| MIC - CONCEPT(TM) RX-2 (K863847) | Microtech Medical Systems, Inc. | 1986-12-18 |
| QUADRA-TITER (TM) I.D. (MODIFICATION) (K861774) | Microtech Medical Systems, Inc. | 1986-05-20 |
| QUADRA-TITER I.D. (K860208) | Microtech Medical Systems, Inc. | 1986-03-03 |
| MIC-CONCEPT SYSTEM (K852613) | Microtech Medical Systems, Inc. | 1985-09-20 |