510(k) K091053 ยท OOU Parainfluenza Multiplex Nucleic Acid Assay
PROPARAFLU+ASSAY
| Applicant | Prodesse, Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, Nov 20, 2009 |
| Received | Apr 13, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091053
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.