The following data is part of a premarket notification filed by Scott Laboratories, Inc. with the FDA for Mug-indole Disc.
| Device ID | K874933 |
| 510k Number | K874933 |
| Device Name: | MUG-INDOLE DISC |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | SCOTT LABORATORIES, INC. 190 N. CITIES SERVICE HWY. Sulphur, LA 70663 |
| Contact | Doris Mcculloch |
| Correspondent | Doris Mcculloch SCOTT LABORATORIES, INC. 190 N. CITIES SERVICE HWY. Sulphur, LA 70663 |
| Product Code | JTO |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-04 |
| Decision Date | 1988-01-05 |