The following data is part of a premarket notification filed by Austin Biological Laboratories with the FDA for Rime Coli Kit.
| Device ID | K832587 |
| 510k Number | K832587 |
| Device Name: | RIME COLI KIT |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | AUSTIN BIOLOGICAL LABORATORIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JTO |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-02 |
| Decision Date | 1983-10-04 |