The following data is part of a premarket notification filed by Trek Diagnostic Systems, Inc. with the FDA for Sensititre 18-24 Hour Susceptibility Plates.
Device ID | K073424 |
510k Number | K073424 |
Device Name: | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES |
Classification | Manual Antimicrobial Susceptibility Test Systems |
Applicant | TREK DIAGNOSTIC SYSTEMS, INC. 982 KEYNOTE CIRCLE SUITE 6 Cleveland, OH 44131 |
Contact | Cynthia C Knapp |
Correspondent | Cynthia C Knapp TREK DIAGNOSTIC SYSTEMS, INC. 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 | 2007-12-05 |
Decision Date | 2008-01-22 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05032384571697 | K073424 | 000 |