510(k) K163390 ยท PAM Gram-Positive Bacteria And Their Resistance Markers
iC-GPC Assay TM for use on the iC-SystemTM
| Applicant | Icubate, Inc., Huntsville AL, US |
| Decision | Substantially Equivalent, Aug 8, 2017 |
| Received | Dec 2, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163390
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.