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, Alere Binaxnow Influenza A & B Card 2 Control Swab Kit.
| Device ID | K162642 |
| 510k Number | K162642 |
| Device Name: | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit |
| Classification | Devices Detecting Influenza A, B, And C Virus Antigens |
| Applicant | ALERE SCARBOROUGH, INC. 10 SOUTHGATE ROAD Scarborough, ME 04074 |
| Contact | Sara Hallowell |
| Correspondent | Sara Hallowell ALERE SCARBOROUGH, INC. 10 SOUTHGATE ROAD 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 | 2016-09-22 |
| Decision Date | 2017-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10811877011214 | K162642 | 000 |
| 10811877011016 | K162642 | 000 |
| 10811877010972 | K162642 | 000 |
| 10811877010156 | K162642 | 000 |
| 00811877010999 | K162642 | 000 |
| 00811877010623 | K162642 | 000 |
| 10811877011009 | K162642 | 000 |
| 10811877010798 | K162642 | 000 |