Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Devices Detecting Influenza A, B, And C Virus Antigens
510(k) Number K162642
Device Name Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
Applicant
ALERE SCARBOROUGH, INC.
10 SOUTHGATE ROAD
SCARBOROUGH,  ME  04074
Applicant Contact SARA HALLOWELL
Correspondent
ALERE SCARBOROUGH, INC.
10 SOUTHGATE ROAD
SCARBOROUGH,  ME  04074
Correspondent Contact SARA HALLOWELL
Regulation Number866.3328
Classification Product Code
PSZ  
Date Received09/22/2016
Decision Date 04/10/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-