K851228 is an FDA 510(k) clearance for the GENERAL DIAGNOSTICS AUGMENTIN 30MCG SUSCEP DISK. This device is classified as a Susceptibility Test Discs, Antimicrobial (Class II - Special Controls, product code JTN).
Submitted by Warner-Lambert Co. (Morris Plains, US). The FDA issued a Cleared decision on April 24, 1985, 29 days after receiving the submission on March 26, 1985.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1620.
| 510(k) Number | K851228 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 1985 |
| Decision Date | April 24, 1985 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JTN — Susceptibility Test Discs, Antimicrobial |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1620 |