Medical Device Manufacturer · US , San Diego , CA

Biosite Incorporated - FDA 510(k) Cleared Devices

46 submissions · 45 cleared · Since 1990

46

Total

45

Cleared

1

Denied

FDA 510(k) Regulatory Record - Biosite Incorporated Chemistry ✕

25 devices

1-25 of 25

Cleared Apr 19, 2010

ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP

Chemistry · 286d

Cleared Nov 13, 2009

TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET

Chemistry · 45d

Cleared Jun 06, 2008

TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS

Chemistry · 126d

Cleared Dec 07, 2007

TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5

Chemistry · 58d

Cleared Jul 10, 2006

TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414

Chemistry · 109d

Cleared Jan 23, 2006

TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200

Chemistry · 112d

Cleared Sep 22, 2005

TRIAGE BNP TEST, MODEL 98000XR

Chemistry · 83d

Cleared Mar 22, 2005

TRIAGE TOX DRUG SCREEN CONTROLS

Chemistry · 74d

Cleared Dec 07, 2004

TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300

Chemistry · 67d

Cleared Jul 06, 2004

TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS

Chemistry · 134d

Cleared Jun 25, 2004

TRIAGE PROFILER S.O.B. PANEL

Chemistry · 127d

Cleared Jan 28, 2004

MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST

Chemistry · 191d

Cleared Dec 23, 2003

TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG...

Chemistry · 61d

Cleared Feb 21, 2003

TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL

Chemistry · 24d

Cleared Jan 23, 2003

TRIAGE CARDIAC CONTROLS

Chemistry · 13d

Cleared Jan 17, 2003

TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER...

Chemistry · 7d

Cleared Jul 01, 2002

TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST

Chemistry · 67d

Cleared Mar 16, 2001

TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000

Chemistry · 46d

Not Cleared Nov 20, 2000

TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST

DEN000010 · NBC

Chemistry · 5d

Cleared Mar 02, 2000

TRIAGE BNP CALIBRATION VERIFICATION CONTROLS

Chemistry · 35d

Cleared Feb 29, 2000

TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS

Chemistry · 33d

Cleared Jan 13, 1998

TRIAGE STATMETER

Chemistry · 117d

Cleared Jan 08, 1998

TRIAGE(R) CARDIAC PANEL CALIBRATION VERIFICATION CONTROLS, TRIAG (R)...

Chemistry · 15d

Cleared Dec 10, 1997

TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL,...

Chemistry · 15d

Cleared Oct 06, 1997

TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN,...

Chemistry · 47d