510(k) DEN120013 ยท OMN C. Difficile Nucleic Acid Amplification Test Assay
PORTRAIT ANALYZER
| Applicant | Great Basin Scientific, Salt Lake City UT, US |
| Decision | Unknown, Apr 30, 2012 |
| Received | Mar 2, 2012 |
| Type | Post-NSE |
| FDA record | Open on fda.gov |
Recalls that name DEN120013
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.