The following data is part of a premarket notification filed by Remel Co. with the FDA for Remel Azithromlycin 15 Mcg Susceptibility Disk.
| Device ID | K933657 |
| 510k Number | K933657 |
| Device Name: | REMEL AZITHROMLYCIN 15 MCG SUSCEPTIBILITY DISK |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Contact | Robert W Feiring |
| Correspondent | Robert W Feiring REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Product Code | JTN |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-27 |
| Decision Date | 1993-10-28 |