The following data is part of a premarket notification filed by Scott Laboratories, Inc. with the FDA for Myco-fluor Reagent A & B.
| Device ID | K874662 |
| 510k Number | K874662 |
| Device Name: | MYCO-FLUOR REAGENT A & B |
| Classification | Stains, Microbiologic |
| Applicant | SCOTT LABORATORIES, INC. 190 N. CITIES SERVICE HWY. Sulphur, LA 70663 |
| Contact | Chrisope, Phd |
| Correspondent | Chrisope, Phd SCOTT LABORATORIES, INC. 190 N. CITIES SERVICE HWY. Sulphur, LA 70663 |
| Product Code | JTS |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-13 |
| Decision Date | 1987-11-25 |