SENSITITRE
FDA premarket approval N50531/S003 · decided 1980-08-13
Approval details
- PMA number
- N50531
- Supplement
- S003
- Trade name
- SENSITITRE
- Generic name
- SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
- Applicant
- Trek Diagnostic Systems, Inc.
- Date received
- 1980-05-19
- Decision date
- 1980-08-13
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- LON
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Sun Prairie, WI
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SENSITITRE 18-24HR SUSCEPTIBILITY PLATES (K093865) | Trek Diagnostic Systems, Inc. | 2010-02-17 |
| SENSITITRE YEASTONE SUSCEPTIBILITY PLATES (K090968) | Trek Diagnostic Systems, Inc. | 2009-06-04 |
| SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES (K083606) | Trek Diagnostic Systems, Inc. | 2009-03-24 |
| SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS (K081063) | Trek Diagnostic Systems, Inc. | 2009-03-06 |
| SENSITITRE VIZION (K081520) | Trek Diagnostic Systems, Inc. | 2008-10-24 |
| SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE (K073653) | Trek Diagnostic Systems, Inc. | 2008-03-20 |
| SENSITITRE 18-24 SUSCEPTIBILITY PLATE (K073558) | Trek Diagnostic Systems, Inc. | 2008-03-13 |
| SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES (K073424) | Trek Diagnostic Systems, Inc. | 2008-01-22 |