K944275 is an FDA 510(k) clearance for the DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG.. This device is classified as a Susceptibility Test Discs, Antimicrobial (Class II - Special Controls, product code JTN).
Submitted by Difco Laboratories, Inc. (Detroit, US). The FDA issued a Cleared decision on December 19, 1994, 111 days after receiving the submission on August 30, 1994.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1620.
| 510(k) Number | K944275 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 1994 |
| Decision Date | December 19, 1994 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | JTN — Susceptibility Test Discs, Antimicrobial |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1620 |