FDA 510(k) Applications for Medical Device Product Code "PSZ"

FDA 510(k) Number Applicant Device Name Decision Date
K133637 ALERE SCARBOROUGH, INC D/B/A BINAX, INC. ALERE INFLUENZA A & B TEST 12/18/2013
K103610 ALERE SCARBOROUGH, INC D/B/A BINAX, INC. CLEARVIEW EXACT II INFLUENZA A & B TEST 01/06/2011
K181853 Alere Scarborough, Inc. Alere BinaxNOW Influenza A & B Card 2, Alere Reader 08/08/2018
K162642 ALERE SCARBOROUGH, INC. Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit 04/10/2017
K173502 Alere Scarborough, Inc. Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit 12/13/2017
K180438 BD BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit 03/20/2018
K001364 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC BD DIRECTIGEN FLU A+B 06/28/2000
K101529 BECTON DICKINSON & CO. BD DIRECTIGEN EZ FLU A+B ASSAY 06/14/2010
K063689 BECTON DICKINSON & CO. BD DIRECTIGEN EZ FLU A+B TEST 03/07/2007
K133138 BECTON DICKINSON & CO. BD VeritorÖ System Flu A+B Assay 11/13/2013
K152870 BECTON DICKINSON AND CO. BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit 10/27/2015
K151291 BECTON DICKINSON AND COMPANY BD Veritor (TM) System for the Rapid Detection of Flu A+B 06/10/2015
K151301 Becton Dickinson and Company BD VeritorÖ System Flu A+B Assay 06/08/2015
K152874 BECTON DICKINSON, AND CO. BD Veritor System for the Rapid Detection of Flu A + B Laboratory kit 10/27/2015
K042472 BECTON, DICKINSON & CO. BD DIRECTIGEN EZ FLU A + B 07/07/2005
K160161 Becton, Dickinson & Co. BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit 02/24/2016
K160164 Becton, Dickinson & Co. BD Veritor System for Rapid Detection of Flu A + B Labratory Kit 02/25/2016
K101461 Becton, Dickinson and Company BD DIRECTIGEN EX FLU A+B 06/24/2010
K132256 Becton, Dickinson and Company BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B 08/07/2013
K132259 Becton, Dickinson and Company BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B 08/07/2013
K132692 Becton, Dickinson and Company BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B 09/23/2013
K120049 Becton, Dickinson and Company BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B 03/23/2012
K112277 Becton, Dickinson and Company BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B 10/28/2011
K121797 Becton, Dickinson and Company BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B 09/07/2012
K132693 Becton, Dickinson and Company BD VeritorÖ System Flu A+B Assay 10/02/2013
K021649 BINAX, INC. BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK 09/19/2002
K021646 BINAX, INC. BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK 09/19/2002
K062109 BINAX, INC. BINAXNOW INFLUENZA A & B TEST 11/09/2006
K053126 BINAX, INC. BINAXNOW INFLUENZA A & B TEST 11/30/2005
K041049 BINAX, INC. BINAXNOW INFLUENZA A & B TEST 08/10/2004
K092223 BINAX, INC. MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST 08/12/2009
K981651 BIOSTAR, INC. AB FLU OIA 11/25/1998
K051244 GENZYME CORP. GENZYME OSOM INFLUENZA A & B TEST 02/21/2006
K061508 GENZYME CORP. OSOM INFLUENZA A&B TEST 06/12/2006
K092633 GENZYME CORPORATION OSOM INFLUENZA A&B TEST , MODEL PN190 09/25/2009
K092349 INVERNESS MEDICAL, INC. CLEARVIEW EXACT II INFLUENZA A & B TEST 05/10/2010
K041626 MERIDIAN BIOSCIENCE, INC. IMMUNOCARD STAT! FLU A & B 03/16/2005
K071657 MERIDIAN BIOSCIENCE, INC. TRU FLU 11/15/2007
K133714 MERIDIAN BIOSCIENCE, INC. TRU FLU 01/03/2014
K092553 MERIDIAN BIOSCIENCE, INC. TRU FLU, MODEL 751230 09/11/2009
K132465 PRINCETON BIOMEDITECH CORP. BIOSIGN FLU A + B, STATUS FLU A & B 09/09/2013
K133474 PRINCETON BIOMEDITECH CORP. BIOSIGN FLU A + B, STATUS FLU A & B 12/10/2013
K083746 PRINCETON BIOMEDITECH CORP. BIOSIGN FLU A+B 11/10/2010
K053146 QUIDEL CORP. QUICKVUE INFLUENZA A + B TEST 12/14/2005
K092698 QUIDEL CORP. QUICKVUE INFLUENZA A+B TEST 09/15/2009
K031899 QUIDEL CORP. QUICKVUE INFLUENZA A+B TEST 09/11/2003
K991633 QUIDEL CORP. QUICKVUE INFLUENZA A/B TEST 09/24/1999
K112177 QUIDEL CORP. SOFIA ANALYZER AND INFLUENZA A+B FIA 10/24/2011
K180288 Quidel Corporation QuickVue Influenza A+B 02/13/2018
K153012 QUIDEL CORPORATION Sofia Influenza A+B FIA 01/12/2016
K162438 Quidel Corporation Sofia Influenza A+B FIA on Sofia 2 04/14/2017
K031565 REMEL INC XPECT INFLUENZA A/B 07/17/2003
K093116 RESPONSE BIOMEDICAL CORP. MODIFICATION TO: RAMP INFLUENZA A/B ASSAY 10/21/2009
K071591 RESPONSE BIOMEDICAL CORP. RAMP INFLUENZA A/B ASSAY 04/16/2008
K011684 ROCHE DIAGNOSTICS CORP. INFLUENZA A/B RAPID TEST, CAT NO 2158 663 11/30/2001
K993048 ROCHE DIAGNOSTICS CORP. ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST 12/20/1999
K100227 SA SCIENTIFIC, INC. SAS FLUALERT A&B, SAS INFLUENZA A TEST 02/23/2010
K080380 SA SCIENTIFIC, INC. SAS INFLUENZA A & B TEST 07/23/2009
K041441 SA SCIENTIFIC, INC. SAS INFLUENZA A TEST 07/22/2004
K041439 SA SCIENTIFIC, INC. SAS INFLUENZA B TEST 07/22/2004
K023556 THERMO BIOSTAR, INC. FLU OIA A/B TEST KIT 03/27/2003
K092423 Thermo Fisher Scientific XPECT FLU A & B 08/26/2009
K982429 ZYMETX, INC. ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES 08/25/1998


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