FDA 510(k) Applications Submitted by QUIDEL CORPORATION

FDA 510(k) Number Submission Date Device Name Applicant
K171976 06/30/2017 Sofia Strep A+ FIA, Sofia 2 Analyzer Quidel Corporation
K153012 10/14/2015 Sofia Influenza A+B FIA QUIDEL CORPORATION
K162911 10/17/2016 Sofia RSV FIA on Sofia 2 analyzer Quidel Corporation
K163713 12/30/2016 Sofia Lyme FIA, Sofia Lyme Control Set Quidel Corporation
K180288 02/01/2018 QuickVue Influenza A+B Quidel Corporation
K162438 08/31/2016 Sofia Influenza A+B FIA on Sofia 2 Quidel Corporation
K173496 11/13/2017 Sofia 2 Lyme FIA, Sofia Lyme Control Set Quidel Corporation
K173691 12/01/2017 Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack Quidel Corporation
K141775 07/01/2014 SOFIA (R) STREP A+ FIA QUIDEL CORPORATION
K131599 06/03/2013 QUICK VUE INFLUENZA QUIDEL CORPORATION
K123793 12/10/2012 SOFIA STREP A FIA QUIDEL CORPORATION
K102175 08/02/2010 RAPIDVUE HCG TEST QUIDEL CORPORATION
K140029 01/06/2014 AMIPLIVUE HSV 1&2 ASSAY QUIDEL CORPORATION
DEN140005 03/25/2014 LYRA DIRECT STREP ASSAY QUIDEL CORPORATION
K150868 04/01/2015 Solana GAS Assay, Solana instrument QUIDEL CORPORATION
K161182 04/27/2016 Solana Trichomonas Assay QUIDEL CORPORATION
K141173 05/06/2014 AMPLIVUE GAS ASSAY QUIDEL CORPORATION
K141927 07/16/2014 LYRA PARAINFLUENZA VIRUS ASSAY QUIDEL CORPORATION
K141931 07/16/2014 LYRA ADENOVIRUS ASSAY QUIDEL CORPORATION
K162274 08/12/2016 Solana Strep Complete Assay Quidel Corporation
K123355 10/31/2012 AMPLIVUE C. DIFFICILE ASSAY QUIDEL CORPORATION
K133503 11/14/2013 AMPLIVUE GBS ASSAY QUIDEL CORPORATION
K143329 11/20/2014 AmpliVue Trichomonas Assay QUIDEL CORPORATION
K133883 12/20/2013 LYRA DIRECT STREP ASSAY QUIDEL CORPORATION
K170491 02/17/2017 Solana C. difficile Assay Quidel Corporation
K181029 04/18/2018 Solana Bordetella Complete Assay Quidel Corporation
K171974 06/30/2017 Solana RSV+hMPV Assay Quidel Corporation
K161814 07/01/2016 Solana Influenza A+B Assay Quidel Corporation
K162451 09/01/2016 Solana HSV 1+2/VZV Assay QUIDEL CORPORATION
K173250 10/10/2017 Solana GBS Assay Quidel Corporation
K143206 11/07/2014 AmpliVue Bordetella Assay QUIDEL CORPORATION


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