The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Dryslide Cefin.
Device ID | K930702 |
510k Number | K930702 |
Device Name: | DRYSLIDE CEFIN |
Classification | Susceptibility Test Discs, Antimicrobial |
Applicant | DIFCO LABORATORIES, INC. P.O. BOX 331058 Detroit, MI 48232 -7058 |
Contact | David W Gates |
Correspondent | David W Gates DIFCO LABORATORIES, INC. P.O. BOX 331058 Detroit, MI 48232 -7058 |
Product Code | JTN |
CFR Regulation Number | 866.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-10 |
Decision Date | 1993-12-22 |