510(k) K032166 ยท GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065
| Applicant | Binax, Inc., Portland ME, US |
| Decision | Substantially Equivalent, Oct 21, 2003 |
| Received | Jul 16, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032166
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 23, 2007 | Binax, Inc. dba IMPD BinaxNOW RSV 10 Test Kit
Part Number : 430-100, contains NP Swabs with '8995' labeled on the swab wrapper Terminated |
GQG | None listed |
| Jul 20, 2004 | Binax, Inc. NOW RSV Test
Item Number 430-430, Kit Number 430-00R Terminated |
GQG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.