The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Maxaquin.
Device ID | K921282 |
510k Number | K921282 |
Device Name: | MAXAQUIN |
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 | 1992-03-17 |
Decision Date | 1992-05-06 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() MAXAQUIN 73725519 1529286 Dead/Cancelled |
G. D. SEARLE & CO. 1988-04-29 |