FDA 510(k) Applications Submitted by Robin Weiner

FDA 510(k) Number Submission Date Device Name Applicant
K060788 03/23/2006 TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414 BIOSITE INCORPORATED
K060791 03/23/2006 TRIAGE TOX DRUG SCREEN, MODEL 94400 BIOSITE INCORPORATED
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.
K132978 09/23/2013 IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST SEQUENOM, INC.
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.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact