The following data is part of a premarket notification filed by Remel Co. with the FDA for Remel Enoxacin 10 Mcg Susceptibility Disk.
Device ID | K925060 |
510k Number | K925060 |
Device Name: | REMEL ENOXACIN 10 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 | 1992-10-06 |
Decision Date | 1992-12-03 |