510(k) K021687 ยท GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK
| Applicant | Binax, Inc., Portland ME, US |
| Decision | Substantially Equivalent, Sep 13, 2002 |
| Received | May 22, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021687
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.