K922792 is an FDA 510(k) clearance for the ZITHROMAX. This device is classified as a Chromatographic, Phospholipids (Class I - General Controls, product code JNT).
Submitted by Difco Laboratories, Inc. (Detroit, US). The FDA issued a Cleared decision on July 30, 1992, 51 days after receiving the submission on June 9, 1992.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 862.1575.
| 510(k) Number | K922792 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 1992 |
| Decision Date | July 30, 1992 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | JNT — Chromatographic, Phospholipids |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1575 |