510(k) K101855 ยท OQW 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
PROFAST+ ASSAY
| Applicant | Gen-Probe Prodesse, Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, Jul 23, 2010 |
| Received | Jul 1, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101855
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.