The following data is part of a premarket notification filed by Alere Scarborough, Inc D/b/a Binax, Inc. with the FDA for Clearview Exact Ii Influenza A & B Test.
| Device ID | K103610 |
| 510k Number | K103610 |
| Device Name: | CLEARVIEW EXACT II INFLUENZA A & B TEST |
| Classification | Devices Detecting Influenza A, B, And C Virus Antigens |
| Applicant | ALERE SCARBOROUGH, INC D/B/A BINAX, INC. 10 Southgate Road Scarborough, ME 04074 |
| Contact | Anne Jepson |
| Correspondent | Anne Jepson ALERE SCARBOROUGH, INC D/B/A BINAX, 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 | 2010-12-09 |
| Decision Date | 2011-01-06 |
| Summary: | summary |