The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Bac-t-screen Bacteriuria Detection Dev.
| Device ID | K823850 |
| 510k Number | K823850 |
| Device Name: | BAC-T-SCREEN BACTERIURIA DETECTION DEV |
| Classification | Kit, Screening, Urine |
| Applicant | MARION LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JXA |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-21 |
| Decision Date | 1983-03-01 |