The following data is part of a premarket notification filed by Trek Diagnostic Systems, Ltd. with the FDA for Sensititre (r) Hp Mic Susceptibility Plate With Cefaroline (0.004-8ug/ml) And The Sensititre (r) 18-24 Hour Mic Susce....
| Device ID | K111429 |
| 510k Number | K111429 |
| Device Name: | SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE... |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | TREK DIAGNOSTIC SYSTEMS, LTD. 982 KEYNOTE CIRCLE SUITE 6 Cleveland, OH 44131 |
| Contact | Cynthia C Knapp |
| Correspondent | Cynthia C Knapp TREK DIAGNOSTIC SYSTEMS, LTD. 982 KEYNOTE CIRCLE SUITE 6 Cleveland, OH 44131 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-23 |
| Decision Date | 2011-08-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848838091551 | K111429 | 000 |
| 00848838091346 | K111429 | 000 |
| 00848838018923 | K111429 | 000 |
| 00848838018855 | K111429 | 000 |
| 00848838018831 | K111429 | 000 |