FDA 510(k) Applications for Medical Device Product Code "PSZ"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K191514 | Access Bio, Inc. | CareStart Flu A&B Plus | 02/18/2020 |
| 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 |
| K223016 | BD | BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit | 01/27/2023 |
| 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 |
| K053126 | BINAX, INC. | BINAXNOW INFLUENZA A & B TEST | 11/30/2005 |
| K062109 | BINAX, INC. | BINAXNOW INFLUENZA A & B TEST | 11/09/2006 |
| 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 |
| K182157 | Princeton BioMeditech Corp. | BioSign Flu A+B | 09/18/2018 |
| K053146 | QUIDEL CORP. | QUICKVUE INFLUENZA A + B TEST | 12/14/2005 |
| K991633 | QUIDEL CORP. | QUICKVUE INFLUENZA A/B TEST | 09/24/1999 |
| K031899 | QUIDEL CORP. | QUICKVUE INFLUENZA A+B TEST | 09/11/2003 |
| K092698 | QUIDEL CORP. | QUICKVUE INFLUENZA A+B TEST | 09/15/2009 |
| 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 |
| K182001 | Sekisui Diagnostics, LLC | Acucy Influenza A&B Test with the Acucy System | 12/17/2018 |
| K192719 | Sekisui Diagnostics, LLC | Osom Ultra Plus Flu A&B Test Kit | 04/03/2020 |
| 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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