K173903 is an FDA 510(k) clearance for the Granada Medium. 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 March 22, 2018, 90 days after receiving the submission on December 22, 2017.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2360. Culture Medium For Gbs Detection.
| 510(k) Number | K173903 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2017 |
| Decision Date | March 22, 2018 |
| Days to Decision | 90 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 |