K874876 is an FDA 510(k) clearance for the GRAM - & GRAM + MIC/COMBO & BREAKPOINT/COMBO PANEL. 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 January 11, 1988, 42 days after receiving the submission on November 30, 1987.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K874876 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 30, 1987 |
| Decision Date | January 11, 1988 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JWY — Manual Antimicrobial Susceptibility Test Systems |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |