The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Augmentin 30 Mcg Sensitivity Disks.
| Device ID | K843172 |
| 510k Number | K843172 |
| Device Name: | AUGMENTIN 30 MCG SENSITIVITY DISKS |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | DIFCO LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JTN |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-13 |
| Decision Date | 1984-09-07 |