K844382 is an FDA 510(k) clearance for the VANCOMYCIN 5MCG DIFFERENTIAL DISK. This device is classified as a Discs, Strips And Reagents, Microorganism Differentiation (Class I - General Controls, product code JTO).
Submitted by Anaerobe Systems (Walker, US). The FDA issued a Cleared decision on January 4, 1985, 52 days after receiving the submission on November 13, 1984.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K844382 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 1984 |
| Decision Date | January 04, 1985 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JTO — Discs, Strips And Reagents, Microorganism Differentiation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |