510(k) K111527 ยท OQO Herpes Simplex Virus Nucleic Acid Amplification Assay
MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT
| Applicant | Eragen Biosciences, Inc., Madison WI, US |
| Decision | Substantially Equivalent, Aug 3, 2011 |
| Received | Jun 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111527
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.