K922458 is an FDA 510(k) clearance for the DRIED GRAM-NEGATIVE AND POSITIVE MIC/COMBO PANELS. This device is classified as a Manual Antimicrobial Susceptibility Test Systems (Class II - Special Controls, product code JWY).
Submitted by Baxter Healthcare Corp (West Sacramento, US). The FDA issued a Cleared decision on December 11, 1992, 199 days after receiving the submission on May 26, 1992.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K922458 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 1992 |
| Decision Date | December 11, 1992 |
| Days to Decision | 199 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 |