K941317 is an FDA 510(k) clearance for the DRIED GRAM NEGATIVE/CEFMETAZOLE. This device is classified as a Manual Antimicrobial Susceptibility Test Systems (Class II - Special Controls, product code JWY).
Submitted by Baxter Diagnostics, Inc. (West Sacramento, US). The FDA issued a Cleared decision on January 31, 1995, 319 days after receiving the submission on March 18, 1994.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K941317 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 1994 |
| Decision Date | January 31, 1995 |
| Days to Decision | 319 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | JWY — Manual Antimicrobial Susceptibility Test Systems |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |