K172150 is an FDA 510(k) clearance for the Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL). This device is classified as a Manual Antimicrobial Susceptibility Test Systems (Class II - Special Controls, product code JWY).
Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on September 15, 2017, 60 days after receiving the submission on July 17, 2017.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K172150 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 2017 |
| Decision Date | September 15, 2017 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| 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 |