The following data is part of a premarket notification filed by Remel Co. with the FDA for Remel Cefepime 30 Ug Susceptibility Disk.
Device ID | K955669 |
510k Number | K955669 |
Device Name: | REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK |
Classification | Susceptibility Test Discs, Antimicrobial |
Applicant | REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
Contact | Mary Ann Silvius |
Correspondent | Mary Ann Silvius 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 | 1995-12-13 |
Decision Date | 1996-02-23 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05032384006991 | K955669 | 000 |