The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Bac-t-screen.
| Device ID | K851399 |
| 510k Number | K851399 |
| Device Name: | BAC-T-SCREEN |
| Classification | Kit, Screening, Urine |
| Applicant | MARION LABORATORIES, INC. P.O. BOX 9627 Kansas City, MI 64134 |
| Contact | William H Guinty |
| Correspondent | William H Guinty MARION LABORATORIES, INC. P.O. BOX 9627 Kansas City, MI 64134 |
| Product Code | JXA |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-09 |
| Decision Date | 1985-06-04 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BAC-T-SCREEN 73418323 1299329 Dead/Cancelled |
Marion Laboratories, Inc. 1983-03-22 |