510(k) K163266 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument
| Applicant | Alere Scarborough, Inc., Scarborough ME, US |
| Decision | Substantially Equivalent, Dec 21, 2016 |
| Received | Nov 21, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163266
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.