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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.
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