510(k) K173932 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2
| Applicant | Alere Scarborough, Inc., Scarborough ME, US |
| Decision | Substantially Equivalent, Jan 26, 2018 |
| Received | Dec 26, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K173932
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.