510(k) K152470 ยท PAM Gram-Positive Bacteria And Their Resistance Markers
Great Basin Staph ID/R Blood Culture Panel
| Applicant | Great Basin Scientific, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Mar 25, 2016 |
| Received | Aug 31, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152470
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 19, 2017 | Great Basin Scientific, Inc. Great Basin Staph lD/R Blood Culture Panel
The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in vitro diagnostic assay intended for use with the P4500 PortraitrM Analyzer Sys Terminated |
PAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.