K170670 is an FDA 510(k) clearance for the Etest Ceftolozane/ Tazobactam (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 May 31, 2017, 86 days after receiving the submission on March 6, 2017.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K170670 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2017 |
| Decision Date | May 31, 2017 |
| Days to Decision | 86 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 |