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 | K173502 |
510k Number | K173502 |
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 | Benjamin Crystal |
Correspondent | Benjamin Crystal 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 | 2017-11-13 |
Decision Date | 2017-12-13 |
Summary: | summary |