The following data is part of a premarket notification filed by Remel Co. with the FDA for Remel Clarithromycin 15 Mcg Susceptibility Disk.
| Device ID | K933118 |
| 510k Number | K933118 |
| Device Name: | REMEL CLARITHROMYCIN 15 MCG SUSCEPTIBILITY DISK |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Contact | Robert Feiring |
| Correspondent | Robert 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 | 1993-06-25 |
| Decision Date | 1993-08-10 |