K170586 is an FDA 510(k) clearance for the Strep B Carrot Broth One-Step. This device is classified as a Gbs Culture Media, Selective And Differential (Class I - General Controls, product code PQZ).
Submitted by Hardy Diagnostics (Santa Maria, US). The FDA issued a Cleared decision on May 22, 2017, 83 days after receiving the submission on February 28, 2017.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2360. Culture Medium For Gbs Detection.
| 510(k) Number | K170586 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2017 |
| Decision Date | May 22, 2017 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | PQZ — Gbs Culture Media, Selective And Differential |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2360 |
| Definition | Culture Medium For Gbs Detection |