K242021 is an FDA 510(k) clearance for the The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/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 October 9, 2024, 90 days after receiving the submission on July 11, 2024.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K242021 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 2024 |
| Decision Date | October 09, 2024 |
| Days to Decision | 90 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 |