FDA 510(k) Applications Submitted by QUIDEL CORP.

FDA 510(k) Number Submission Date Device Name Applicant
K981722 05/15/1998 QUIDEL HOME PREGNANCY TEST QUIDEL CORP.
K974108 10/31/1997 SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE) QUIDEL CORP.
K070747 03/19/2007 QUICK VUE RSV TEST, MODELS 20193, 20199 QUIDEL CORP.
K040008 01/02/2004 QUICKVUE ADVANCE PH AND AMINES GLL TEST QUIDEL CORP.
K020799 03/12/2002 QUICKVUE ONE-STEP HCG-URINE QUIDEL CORP.
K020801 03/12/2002 QUICKVUE ONE-STEP HCG-COMBO QUIDEL CORP.
K101918 07/09/2010 QUICKVUE RSV 10 QUIDEL CORP.
K061008 04/12/2006 QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199 QUIDEL CORP.
K131166 04/24/2013 SOFIA(R) HCG FIA QUIDEL CORP.
K131619 06/03/2013 QUICKVUE INFLUENZA A+B QUIDEL CORP.
K112177 07/28/2011 SOFIA ANALYZER AND INFLUENZA A+B FIA QUIDEL CORP.
K092698 09/02/2009 QUICKVUE INFLUENZA A+B TEST QUIDEL CORP.
K053146 11/10/2005 QUICKVUE INFLUENZA A + B TEST QUIDEL CORP.
K130398 02/19/2013 SOFIA(R) RSV FIA QUIDEL CORP.
K131606 06/03/2013 SOFIA INFLUENZA A+B FIA QUIDEL CORP.
K991633 05/12/1999 QUICKVUE INFLUENZA A/B TEST QUIDEL CORP.
K011097 04/11/2001 QUICKVUE DIPSTICK STREP A QUIDEL CORP.
K991747 05/21/1999 QUICKVUE ONE-STEP H. PYLORI II TEST QUIDEL CORP.
K952517 05/31/1995 QUICKVUE ONE-STEP HELICOBACTOR PYLORI TEST QUIDEL CORP.
K031899 06/04/2003 QUICKVUE INFLUENZA A+B TEST QUIDEL CORP.
K972742 07/23/1997 QUICKVUE ONE-STEP HCG-URINE QUIDEL CORP.
K972748 07/23/1997 CARDS Q.S. HCG-URINE; AND CONCISE PERFORMANCE PLUS HCG-URINE QUIDEL CORP.
K022851 08/27/2002 PH AND AMINES EXTERNAL CONTROL SET QUIDEL CORP.
K973858 10/09/1997 CARDS Q.S. HCG SERUM/URINE;CONCISE PERFORMANCE PLUS HCG-COMBO QUIDEL CORP.
K974052 10/27/1997 QUICKVUE SEMI-Q HCG-COMBO QUIDEL CORP.
K974111 10/31/1997 QUIDEL CH50 EQ EIA QUIDEL CORP.
K955108 11/08/1995 CARDS Q.S. STREP A QUIDEL CORP.
K974821 12/23/1997 BLUETEST(R) PREGNANCY TEST, RAPIDVUE(R) PREGNANCY TEST QUIDEL CORP.
K973841 10/08/1997 QUICKVUE ONE-STEP HCG-COMBO QUIDEL CORP.
K112172 07/28/2011 QUIDEL MOLECULAR INFLUENZA A + B ASSAY QUIDEL CORP.
K131728 06/12/2013 QUIDEL MOLECULAR INFLUENZA A + B ASSAY QUIDEL CORP.
K131813 06/20/2013 QUIDEL MOLECULAR RSV + HMPV ASSAY QUIDEL CORP.
K122189 07/24/2012 QUIDEL MOLECULAR RSV + HMPV ASSAY QUIDEL CORP.
K112490 08/29/2011 QUIDEL MOLECULAR HMPV ASSAY QUIDEL CORP.
K113777 12/21/2011 QUIDEL MOLECULAR INFLUENZA A+B QUIDEL CORP.
K123998 12/26/2012 QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY QUIDEL CORP.


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