The following data is part of a premarket notification filed by Binax, Inc. with the FDA for Binaxnow Influenza A & B Test.
| Device ID | K053126 |
| 510k Number | K053126 |
| Device Name: | BINAXNOW INFLUENZA A & B TEST |
| Classification | Devices Detecting Influenza A, B, And C Virus Antigens |
| Applicant | BINAX, INC. 10 SOUTHGATE RD. Scarborough, ME 04074 |
| Contact | Angela Drysdale |
| Correspondent | Angela Drysdale BINAX, INC. 10 SOUTHGATE RD. Scarborough, ME 04074 |
| Product Code | PSZ |
| CFR Regulation Number | 866.3328 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-07 |
| Decision Date | 2005-11-30 |
| Summary: | summary |