The following data is part of a premarket notification filed by Trek Diagnostic Systems, Inc. with the FDA for Versatrek Myco Pza Kit.
| Device ID | K052323 |
| 510k Number | K052323 |
| Device Name: | VERSATREK MYCO PZA KIT |
| Classification | Susceptibility Test Powders, Antimycobacterial |
| Applicant | TREK DIAGNOSTIC SYSTEMS, INC. 210 BUSINESS PARK DR. Sun Prairie, WI 53590 |
| Contact | Nadine M Sullivan |
| Correspondent | Nadine M Sullivan TREK DIAGNOSTIC SYSTEMS, INC. 210 BUSINESS PARK DR. Sun Prairie, WI 53590 |
| Product Code | MJA |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-25 |
| Decision Date | 2006-01-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848838091834 | K052323 | 000 |