Medical Device Manufacturer · US , San Diego , CA

Biosite Incorporated

46 submissions · 45 cleared · Since 1990
46
Total
45
Cleared
1
Denied

Biosite Incorporated — FDA 510(k) Submissions

Biosite Incorporated has submitted 46 FDA 510(k) premarket notifications since 1990, of which 45 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Test, Natriuretic Peptide, Enzyme Immunoassay, Amphetamine, Multi-analyte Controls, All Kinds (assayed), Drug Mixture Control Materials, Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control . Use the specialty filter in the sidebar to narrow results.

46 devices
1–25 of 46
INRATIO/INRATIO2 TEST STRIPS
K092987 · GJS Test, Time, Prothrombin · Hematology
Jun 2010 256d
ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP
K092048 · DJR Enzyme Immunoassay,... · Chemistry
Apr 2010 286d
TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET
K093032 · JJY Multi-analyte Controls,... · Chemistry
Nov 2009 45d
TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS
K080269 · NBC Test, Natriuretic Peptide · Chemistry
Jun 2008 126d
TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5
K072892 · JJY Multi-analyte Controls,... · Chemistry
Dec 2007 58d
TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS
K062840 · GGN Plasma, Coagulation Control · Hematology
Mar 2007 160d
TRIAGE PROTEIN C TEST
K062530 · GGP Test, Qualitative And... · Hematology
Jan 2007 153d
TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414
K060788 · DIF Drug Mixture Control... · Chemistry
Jul 2006 109d
TRIAGE TOX DRUG SCREEN, MODEL 94400
K060791 · DJR Enzyme Immunoassay,... · Toxicology
Jun 2006 91d
TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200
K052789 · NBC Test, Natriuretic Peptide · Chemistry
Jan 2006 112d
TRIAGE BNP TEST, MODEL 98000XR
K051787 · NBC Test, Natriuretic Peptide · Chemistry
Sep 2005 83d
TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS
K050799 · GGN Plasma, Coagulation Control · Hematology
Jun 2005 91d
TRIAGE TOX DRUG SCREEN CONTROLS
K050037 · DIF Drug Mixture Control... · Chemistry
Mar 2005 74d
TRIAGE TOX DRUG SCREEN
K043242 · LDP Colorimetry, Acetaminophen · Toxicology
Feb 2005 97d
TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300
K042723 · DAP Fibrinogen And Fibrin... · Chemistry
Dec 2004 67d
TRIAGE D-DIMER TEST, MODEL 98100
K042890 · GHH Fibrin Split Products · Hematology
Nov 2004 41d
TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS
K040459 · JJY Multi-analyte Controls,... · Chemistry
Jul 2004 134d
TRIAGE PROFILER S.O.B. PANEL
K040437 · DAP Fibrinogen And Fibrin... · Chemistry
Jun 2004 127d
MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
K032235 · NBC Test, Natriuretic Peptide · Chemistry
Jan 2004 191d
TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200
K033383 · NBC Test, Natriuretic Peptide · Chemistry
Dec 2003 61d
TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL
K030286 · NBC Test, Natriuretic Peptide · Chemistry
Feb 2003 24d
TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS
K030089 · JJY Multi-analyte Controls,... · Chemistry
Jan 2003 13d
TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION CONTROLS
K030088 · JJY Multi-analyte Controls,... · Chemistry
Jan 2003 7d
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
K021317 · NBC Test, Natriuretic Peptide · Chemistry
Jul 2002 67d
TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002
K014247 · DKZ Enzyme Immunoassay,... · Toxicology
Jun 2002 159d
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