510(k) K140198 ยท OQO Herpes Simplex Virus Nucleic Acid Amplification Assay
IMDX HSV-1/2 FOR ABBOTT M2000
| Applicant | Intelligent Medical Devices, Inc., Beverly MA, US |
| Decision | Substantially Equivalent, May 13, 2014 |
| Received | Jan 27, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140198
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.