510(k) K170586 ยท PQZ Gbs Culture Media, Selective And Differential
Strep B Carrot Broth One-Step
| Applicant | Hardy Diagnostics, Santa Maria CA, US |
| Decision | Substantially Equivalent, May 22, 2017 |
| Received | Feb 28, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170586
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 6, 2020 | Hardy Diagnostics Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499 Terminated |
PQZ | None listed |
| Apr 20, 2020 | Cardinal Health Inc. Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant w Terminated |
PQZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.