510(k) K132237 ยท OQW 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
PRODESSE PROFAST+ ASSAY
| Applicant | Gen-Probe Prodesse, Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, Aug 26, 2013 |
| Received | Jul 18, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K132237
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.