K142338 is an FDA 510(k) clearance for the Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml). This device is classified as a Manual Antimicrobial Susceptibility Test Systems (Class II - Special Controls, product code JWY).
Submitted by Thermo Fisher Scientific (Oakwood Village, US). The FDA issued a Cleared decision on March 2, 2015, 193 days after receiving the submission on August 21, 2014.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K142338 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 2014 |
| Decision Date | March 02, 2015 |
| Days to Decision | 193 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 |