The following data is part of a premarket notification filed by Alere Scarborough, Inc. with the FDA for Alere Binaxnow Influenza A & B Card 2, Alere Reader.
| Device ID | K181853 |
| 510k Number | K181853 |
| Device Name: | Alere BinaxNOW Influenza A & B Card 2, Alere Reader |
| Classification | Devices Detecting Influenza A, B, And C Virus Antigens |
| Applicant | Alere Scarborough, Inc. 10 Southgate Road Scarborough, ME 04074 |
| Contact | Angela Drysdale |
| Correspondent | Angela Drysdale Alere Scarborough, Inc. 10 Southgate Road Scarborough, ME 04074 |
| Product Code | PSZ |
| CFR Regulation Number | 866.3328 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-11 |
| Decision Date | 2018-08-08 |
| Summary: | summary |