The following data is part of a premarket notification filed by Trek Diagnostic Systems, Inc. with the FDA for Esp Culture System Ii - Myco Susceptibility Testing.
| Device ID | K972772 |
| 510k Number | K972772 |
| Device Name: | ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING |
| Classification | Susceptibility Test Powders, Antimycobacterial |
| Applicant | TREK DIAGNOSTIC SYSTEMS, INC. 29299 CLEMENS RD., SUITE 1-K Westlake, OH 44145 |
| Contact | Nadine Sullivan |
| Correspondent | Nadine Sullivan TREK DIAGNOSTIC SYSTEMS, INC. 29299 CLEMENS RD., SUITE 1-K Westlake, OH 44145 |
| Product Code | MJA |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-24 |
| Decision Date | 1999-07-13 |