K163042 is an FDA 510(k) clearance for the chromID Strepto B agar. This device is classified as a Gbs Culture Media, Selective And Differential (Class I - General Controls, product code PQZ).
Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on January 27, 2017, 88 days after receiving the submission on October 31, 2016.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2360. Culture Medium For Gbs Detection.
| 510(k) Number | K163042 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2016 |
| Decision Date | January 27, 2017 |
| Days to Decision | 88 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 |