K170481 is an FDA 510(k) clearance for the Strep B Carrot Broth Kit. 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 16, 2017, 89 days after receiving the submission on February 16, 2017.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2360. Culture Medium For Gbs Detection.
| 510(k) Number | K170481 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 16, 2017 |
| Decision Date | May 16, 2017 |
| Days to Decision | 89 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 |