510(k) K081030 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
MODIFICATION TO PROFLU+ ASSAY
| Applicant | Prodesse, Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, May 2, 2008 |
| Received | Apr 11, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081030
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.