K152346 is an FDA 510(k) clearance for the MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL). This device is classified as a Manual Antimicrobial Susceptibility Test Systems (Class II - Special Controls, product code JWY).
Submitted by Beckman Coulter, Inc. (West Sacramento, US). The FDA issued a Cleared decision on September 16, 2015, 27 days after receiving the submission on August 20, 2015.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K152346 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 2015 |
| Decision Date | September 16, 2015 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | JWY — Manual Antimicrobial Susceptibility Test Systems |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |