510(k) K131584 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
IMDX FLU A/B AND RSV FOR ABBOTT M2000
| Applicant | Intelligent Medical Devices, Inc., Beverly MA, US |
| Decision | Substantially Equivalent, Aug 21, 2013 |
| Received | May 31, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131584
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.