510(k) K092500 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
MODIFICATION TO PROFLU+ ASSAY
| Applicant | Prodesse, Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, Aug 20, 2009 |
| Received | Aug 14, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K092500
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.