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 |