The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for Cefepine Antimicrobial Susceptibility Test Disc.
Device ID | K964495 |
510k Number | K964495 |
Device Name: | CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
Classification | Susceptibility Test Discs, Antimicrobial |
Applicant | UNIPATH LTD. 15 OAK ST. Beverly Farms, MA 01915 |
Contact | Fran White |
Correspondent | Fran White UNIPATH LTD. 15 OAK ST. Beverly Farms, MA 01915 |
Product Code | JTN |
CFR Regulation Number | 866.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-11-08 |
Decision Date | 1997-02-07 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05032384006991 | K964495 | 000 |