The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Bac-t-screen.
| Device ID | K833917 |
| 510k Number | K833917 |
| Device Name: | BAC-T-SCREEN |
| Classification | Monitor, Microbial Growth |
| Applicant | MARION LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JTA |
| CFR Regulation Number | 866.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-14 |
| Decision Date | 1984-01-13 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BAC-T-SCREEN 73418323 1299329 Dead/Cancelled |
Marion Laboratories, Inc. 1983-03-22 |