The following data is part of a premarket notification filed by Scott Laboratories, Inc. with the FDA for B. Cat Confirm.
| Device ID | K880694 |
| 510k Number | K880694 |
| Device Name: | B. CAT CONFIRM |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | SCOTT LABORATORIES, INC. 190 NORTH CITIES SERVICE HWY. Sulphur, CA 70663 |
| Contact | Doris Mucculloch |
| Correspondent | Doris Mucculloch SCOTT LABORATORIES, INC. 190 NORTH CITIES SERVICE HWY. Sulphur, CA 70663 |
| Product Code | JTO |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-22 |
| Decision Date | 1988-06-16 |