510(k) K100148 ยท OQW 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500
| Applicant | Focus Diagnostics, Inc., Cypress CA, US |
| Decision | Substantially Equivalent, May 24, 2010 |
| Received | Jan 19, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100148
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.