510(k) K093784 ยท OPM Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2
ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM
| Applicant | Zeus Scientific, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Jul 16, 2010 |
| Received | Dec 9, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093784
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.