BAC-T-SCREEN
Kit, Screening, Urine
BIOMERIEUX VITEK, INC.
The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Bac-t-screen.
Pre-market Notification Details
| Device ID | K924218 |
| 510k Number | K924218 |
| Device Name: | BAC-T-SCREEN |
| Classification | Kit, Screening, Urine |
| Applicant | BIOMERIEUX VITEK, INC. 595 ANGLUM DR. Hazelwood, MO 63042 -2395 |
| Contact | David K Broadway |
| Correspondent | David K Broadway BIOMERIEUX VITEK, INC. 595 ANGLUM DR. Hazelwood, MO 63042 -2395 |
| Product Code | JXA |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-20 |
| Decision Date | 1993-02-03 |
Trademark Results [BAC-T-SCREEN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BAC-T-SCREEN 73418323 1299329 Dead/Cancelled |
Marion Laboratories, Inc. 1983-03-22 |
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