The following data is part of a premarket notification filed by Trek Diagnostic Systems, Inc. with the FDA for Sensititre Yeastone Susceptibility Plates.
Device ID | K090968 |
510k Number | K090968 |
Device Name: | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES |
Classification | Susceptibility Test Plate, Antifungal |
Applicant | TREK DIAGNOSTIC SYSTEMS, INC. 982 KEYNOTE CIRCLE SUITE 6 Cleveland, OH 44131 |
Contact | Cynthia Knapp |
Correspondent | Cynthia Knapp TREK DIAGNOSTIC SYSTEMS, INC. 982 KEYNOTE CIRCLE SUITE 6 Cleveland, OH 44131 |
Product Code | NGZ |
CFR Regulation Number | 866.1640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-04-06 |
Decision Date | 2009-06-04 |