510(k) DEN130049 ยท PGH Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel
SIMPLEXA HSV 1&2 DIRECT
| Applicant | Focus Diagnostics, Cypress CA, US |
| Decision | Unknown, Mar 21, 2014 |
| Received | Nov 25, 2013 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN130049
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.