The following data is part of a premarket notification filed by Binax, Inc. with the FDA for Binax Now Flu B Test (27 Test), Binax Now Nasopharyngeal Swab Specimen Accesory Pack.
| Device ID | K021646 |
| 510k Number | K021646 |
| Device Name: | BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK |
| Classification | Devices Detecting Influenza A, B, And C Virus Antigens |
| Applicant | BINAX, INC. 217 READ ST. Portland, ME 04103 |
| Contact | Anne Jepson |
| Correspondent | Anne Jepson BINAX, INC. 217 READ ST. Portland, ME 04103 |
| Product Code | PSZ |
| CFR Regulation Number | 866.3328 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-20 |
| Decision Date | 2002-09-19 |
| Summary: | summary |