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510(k) K133411

Device
ALERE BINAXNOW INFLUENZA A & B CARD
Applicant
ALERE SCARBOROUGH, INC D/B/A BINAX, INC.
510(k) number
K133411
Product code
GNX  
Decision
Substantially Equivalent (SESE)
Decision date
2013-12-05
Date received
2013-11-07
Regulation
866.3330
Classification name
Antigens, Cf (including Cf Control), Influenza Virus A, B, C
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Angela Drysdale
Address
10 Southgate Rd. Scarborough ME US 04074 04074

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GNX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K132352SAS FLUALERT A & B, SAS INFLUENZA A TESTSa Scientific , Ltd.2013-08-22
K131804REMEL XPECT FLU A&BRemel, Inc.2013-07-12
K131599QUICK VUE INFLUENZAQuidel Corporation2013-07-05
K131606SOFIA INFLUENZA A+B FIAQuidel Corp.2013-07-05
K131619QUICKVUE INFLUENZA A+BQuidel Corp.2013-06-28
K123182OSOM INFLUENZA A&B TEST MODEL 190SEKISUI Diagnostics, LLC2012-11-05
K971494VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSESZymetx, Inc.1997-09-10
K924006BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAYBaxter Healthcare Corp1992-12-29
K901493FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE BWhittaker Bioproducts, Inc.1990-06-27
K893579FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE AWhittaker Bioproducts, Inc.1990-01-16
K884191INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTIONBaxter Diagnostics, Inc.1988-11-22
K872958IMAGEN INFLUENZA VIRUS A AND B TESTMIBoots-Celltech Diagnostics, Inc.1988-02-24
K871231ANTIBODY ASSAY FOR DETECTION OF INFLUENZA BMicroscan Div. Baxter Healthcare Corp.1987-06-26
K871233ANTIBODY ASSAY FOR DETECTION OF INFLUENZA AMicroscan Div. Baxter Healthcare Corp.1987-06-26
K843659INFLUENZA A2 VIRUSInstitute Virion , Ltd.1985-09-26

Legacy Summary#

summary

FDA Review#

Decision Summary