510(k) K062109 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
BINAXNOW INFLUENZA A & B TEST
| Applicant | Binax, Inc., Scarborough ME, US |
| Decision | Substantially Equivalent, Nov 9, 2006 |
| Received | Jul 24, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062109
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 23, 2007 | Binax, Inc. dba IMPD BinaxNOW Influenza A&B 10 Test KIT
Part Number: 416-110 contains NP Swabs with '8995' labeled on the swab wrapper Terminated |
GNX | None listed |
| May 23, 2007 | Binax, Inc. dba IMPD BinaxNOW Influenza A&B 22 Test Kit
Part Number: 416-022, contains NP Swabs with '8995' labeled on the swab wrapper Terminated |
GNX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.