510(k) K100336 ยท OQO Herpes Simplex Virus Nucleic Acid Amplification Assay
MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711
| Applicant | Eragen Biosciences, Madison WI, US |
| Decision | Substantially Equivalent, May 12, 2010 |
| Received | Feb 5, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100336
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.