The following data is part of a premarket notification filed by Trek Diagnostic Systems, Inc. with the FDA for Sensititre 18-24 Hr Susceptibility Plates(addition Of Meropenem).
| Device ID | K983244 |
| 510k Number | K983244 |
| Device Name: | SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM) |
| Classification | System, Transport, Aerobic |
| 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 | JTW |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-16 |
| Decision Date | 1998-11-30 |