The following data is part of a premarket notification filed by Warner-lambert Co. with the FDA for General Diagnostics Augmentin 30mcg Suscep Disk.
| Device ID | K851228 |
| 510k Number | K851228 |
| Device Name: | GENERAL DIAGNOSTICS AUGMENTIN 30MCG SUSCEP DISK |
| Classification | Susceptibility Test Discs, Antimicrobial |
| Applicant | WARNER-LAMBERT CO. 201 TABOR RD. Morris Plains, NJ 07950 |
| Contact | Lynn Decaro |
| Correspondent | Lynn Decaro WARNER-LAMBERT CO. 201 TABOR RD. Morris Plains, NJ 07950 |
| Product Code | JTN |
| CFR Regulation Number | 866.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-26 |
| Decision Date | 1985-04-24 |