FDA 510(k) Applications Submitted by RONALD H. LOLLAR

FDA 510(k) Number Submission Date Device Name Applicant
K112172 07/28/2011 QUIDEL MOLECULAR INFLUENZA A + B ASSAY QUIDEL CORP.
K140029 01/06/2014 AMIPLIVUE HSV 1&2 ASSAY QUIDEL CORPORATION
DEN140004 02/21/2014 QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY DIAGNOSTIC HYBRIDS, INC.
DEN140005 03/25/2014 LYRA DIRECT STREP ASSAY QUIDEL CORPORATION
K150868 04/01/2015 Solana GAS Assay, Solana instrument QUIDEL CORPORATION
K091171 04/22/2009 D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT DIAGNOSTIC HYBRIDS, INC.
K161182 04/27/2016 Solana Trichomonas Assay QUIDEL CORPORATION
K141173 05/06/2014 AMPLIVUE GAS ASSAY QUIDEL CORPORATION
K131728 06/12/2013 QUIDEL MOLECULAR INFLUENZA A + B ASSAY QUIDEL CORP.
K091753 06/16/2009 ELVIS HSV ID AND D3 TYPING TEST SYSTEM DIAGNOSTIC HYBRIDS, INC.
K131813 06/20/2013 QUIDEL MOLECULAR RSV + HMPV ASSAY QUIDEL CORP.
K141927 07/16/2014 LYRA PARAINFLUENZA VIRUS ASSAY QUIDEL CORPORATION
K141931 07/16/2014 LYRA ADENOVIRUS ASSAY QUIDEL CORPORATION
K092229 07/23/2009 THYRETAIN TM TSI REPORTER BIOASSAY DIAGNOSTIC HYBRIDS, INC.
K122189 07/24/2012 QUIDEL MOLECULAR RSV + HMPV ASSAY QUIDEL CORP.
K092300 07/29/2009 MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT DIAGNOSTIC HYBRIDS, INC.
K162274 08/12/2016 Solana Strep Complete Assay Quidel Corporation
K112490 08/29/2011 QUIDEL MOLECULAR HMPV ASSAY QUIDEL CORP.
K092882 09/18/2009 D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT DIAGNOSTIC HYBRIDS, INC.
K093233 10/14/2009 D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT DIAGNOSTIC HYBRIDS, INC.
K123355 10/31/2012 AMPLIVUE C. DIFFICILE ASSAY QUIDEL CORPORATION
K093415 11/02/2009 D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT DIAGNOSTIC HYBRIDS, INC.
K133503 11/14/2013 AMPLIVUE GBS ASSAY QUIDEL CORPORATION
K143329 11/20/2014 AmpliVue Trichomonas Assay QUIDEL CORPORATION
K113777 12/21/2011 QUIDEL MOLECULAR INFLUENZA A+B QUIDEL CORP.
K123998 12/26/2012 QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY QUIDEL CORP.
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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