510(k) K111951 ยท OQO Herpes Simplex Virus Nucleic Acid Amplification Assay
ISOAMP HSV ASSAY
| Applicant | Biohelix Corporation, Beverly MA, US |
| Decision | Substantially Equivalent, Sep 27, 2011 |
| Received | Jul 8, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111951
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.