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

1-12 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