510(k) K190341 ยท PEN Gram-Negative Bacteria And Associated Resistance Markers
iC-GN iC-Cassette for use on the iC-System
| Applicant | Icubate, Inc., Huntsville AL, US |
| Decision | Substantially Equivalent, Jun 28, 2019 |
| Received | Feb 14, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190341
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.