The following data is part of a premarket notification filed by G.d. Searle And Co. with the FDA for Metronidazole Discs.
| Device ID | K801805 |
| 510k Number | K801805 |
| Device Name: | METRONIDAZOLE DISCS |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | G.D. SEARLE AND CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-29 |
| Decision Date | 1981-02-10 |