K792349 is an FDA 510(k) clearance for the SUSCEPTIBILITY DISK, CINOXACIN 100 MCG.. This device is classified as a Chromatographic, Phospholipids (Class I - General Controls, product code JNT).
Submitted by Pfizer, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 12, 1980, 114 days after receiving the submission on November 19, 1979.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 862.1575.
| 510(k) Number | K792349 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 1979 |
| Decision Date | March 12, 1980 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JNT — Chromatographic, Phospholipids |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1575 |