FDA 510(k) Applications Submitted by BIOSITE INCORPORATED

FDA 510(k) Number Submission Date Device Name Applicant
K080269 02/01/2008 TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS BIOSITE INCORPORATED
K062530 08/29/2006 TRIAGE PROTEIN C TEST BIOSITE INCORPORATED
K062840 09/22/2006 TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS BIOSITE INCORPORATED
K072892 10/10/2007 TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5 BIOSITE INCORPORATED
DEN000010 11/15/2000 TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST BIOSITE INCORPORATED
K021317 04/25/2002 TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST BIOSITE INCORPORATED
K042890 10/19/2004 TRIAGE D-DIMER TEST, MODEL 98100 BIOSITE INCORPORATED
K051787 07/01/2005 TRIAGE BNP TEST, MODEL 98000XR BIOSITE INCORPORATED
K050037 01/07/2005 TRIAGE TOX DRUG SCREEN CONTROLS BIOSITE INCORPORATED
K030088 01/10/2003 TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION CONTROLS BIOSITE INCORPORATED
K030089 01/10/2003 TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS BIOSITE INCORPORATED
K030286 01/28/2003 TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL BIOSITE INCORPORATED
K010266 01/29/2001 TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000 BIOSITE INCORPORATED
K040437 02/19/2004 TRIAGE PROFILER S.O.B. PANEL BIOSITE INCORPORATED
K040459 02/23/2004 TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS BIOSITE INCORPORATED
K032235 07/21/2003 MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST BIOSITE INCORPORATED
K012745 08/16/2001 TRIAGE TOX DRUG SCREEN, CATALOG #94000 BIOSITE INCORPORATED
K012999 09/06/2001 TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001 BIOSITE INCORPORATED
K013002 09/06/2001 TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002 BIOSITE INCORPORATED
K043242 11/23/2004 TRIAGE TOX DRUG SCREEN BIOSITE INCORPORATED
K014247 12/26/2001 TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002 BIOSITE INCORPORATED
K033383 10/23/2003 TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200 BIOSITE INCORPORATED
K042723 10/01/2004 TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300 BIOSITE INCORPORATED
K000230 01/27/2000 TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS BIOSITE INCORPORATED
K000231 01/27/2000 TRIAGE BNP CALIBRATION VERIFICATION CONTROLS BIOSITE INCORPORATED
K982245 06/26/1998 TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE CRYPTOSPORIDIUM AND GIARDIA LAMBLIA BIOSITE INCORPORATED
K973126 08/20/1997 TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I BIOSITE INCORPORATED
K973547 09/18/1997 TRIAGE STATMETER BIOSITE INCORPORATED
K973784 10/03/1997 TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS BIOSITE INCORPORATED
K974461 11/25/1997 TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL, TRIAGE MYOGLOBIN CONTROL BIOSITE INCORPORATED
K955934 12/13/1995 TRIAGE PANEL FOR DRUGS OF ABUSE MODEL 9500/93000 BIOSITE INCORPORATED
K955935 12/13/1995 TRIAGE PANEL FOR DRUGS OF ABUSE/TRICYCLIC ANTIDEPRESSANTS BIOSITE INCORPORATED
K974827 12/24/1997 TRIAGE(R) CARDIAC PANEL CALIBRATION VERIFICATION CONTROLS, TRIAG (R) MYOGLOBIN CALIBRATION VERIFICATION CONTROLS, TRIAGE BIOSITE INCORPORATED
K974881 12/30/1997 TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A BIOSITE INCORPORATED
K092987 09/28/2009 INRATIO/INRATIO2 TEST STRIPS BIOSITE INCORPORATED
K092048 07/07/2009 ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP BIOSITE INCORPORATED
K093032 09/29/2009 TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET BIOSITE INCORPORATED
K050799 03/30/2005 TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS BIOSITE INCORPORATED
K052789 10/03/2005 TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200 BIOSITE INCORPORATED
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


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