The following data is part of a premarket notification filed by Alere Scarborough, Inc D/b/a Binax, Inc. with the FDA for Alere Binaxnow Influenza A & B Card.
| Device ID | K133411 |
| 510k Number | K133411 |
| Device Name: | ALERE BINAXNOW INFLUENZA A & B CARD |
| Classification | Antigens, Cf (including Cf Control), Influenza Virus A, B, C |
| Applicant | ALERE SCARBOROUGH, INC D/B/A BINAX, INC. 10 Southgate Rd Scarborough, ME 04074 |
| Contact | Angela Drysdale |
| Correspondent | Angela Drysdale ALERE SCARBOROUGH, INC D/B/A BINAX, INC. 10 Southgate Rd Scarborough, ME 04074 |
| Product Code | GNX |
| CFR Regulation Number | 866.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-07 |
| Decision Date | 2013-12-05 |
| Summary: | summary |