510(k) K172509 ยท OQO Herpes Simplex Virus Nucleic Acid Amplification Assay
Sentosa SA201 HSV 1/2 Qualitative PCR Test
| Applicant | Vela Diagnostics USA, Inc., Fairfield NJ, US |
| Decision | Substantially Equivalent, Feb 1, 2018 |
| Received | Aug 21, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172509
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.