Biosite Incorporated

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
46
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K092987INRATIO/INRATIO2 TEST STRIPSJune 11, 2010
K092048ONE STEP EDDP (METHADONE METABOLITE) TEST STRIPApril 19, 2010
K093032TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SETNovember 13, 2009
K080269TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELSJune 6, 2008
K072892TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5December 7, 2007
K062840TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLSMarch 1, 2007
K062530TRIAGE PROTEIN C TESTJanuary 29, 2007
K060788TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414July 10, 2006
K060791TRIAGE TOX DRUG SCREEN, MODEL 94400June 22, 2006
K052789TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200January 23, 2006
K051787TRIAGE BNP TEST, MODEL 98000XRSeptember 22, 2005
K050799TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLSJune 29, 2005
K050037TRIAGE TOX DRUG SCREEN CONTROLSMarch 22, 2005
K043242TRIAGE TOX DRUG SCREENFebruary 28, 2005
K042723TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300December 7, 2004
K042890TRIAGE D-DIMER TEST, MODEL 98100November 29, 2004
K040459TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLSJuly 6, 2004
K040437TRIAGE PROFILER S.O.B. PANELJune 25, 2004
K032235MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TESTJanuary 28, 2004
K033383TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200December 23, 2003