510(k) K110968 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
PROFLU+ ASSAY
| Applicant | Gen-Probe Prodesse, Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, Jun 27, 2011 |
| Received | Apr 6, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110968
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.