The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Cefzil.
| Device ID | K922793 | 
| 510k Number | K922793 | 
| Device Name: | CEFZIL | 
| 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 | 1992-06-09 | 
| Decision Date | 1992-07-28 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  CEFZIL  74128079  1742095 Dead/Cancelled | Bristol-Myers Squibb Company 1991-01-03 |