510(k) K163042 ยท PQZ Gbs Culture Media, Selective And Differential
chromID Strepto B agar
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Jan 27, 2017 |
| Received | Oct 31, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163042
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc PPM CLINICAL CHROMID STREPTO B US 20 PLT, CATALOG 419751 Open, Classified |
PQZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.