Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

47 results for "Biosite Incorporated"
1–24 of 47
Search insights Median review: 74d Cleared: 98% Top manufacturer: Biosite Incorporated Lead specialty: Chemistry
Cleared Dec 21, 2010
LIPID CONTROLS
K102700 · JJY
Alere, San Diego, Dba Biosite...
Chemistry · 92d
Cleared Jun 11, 2010
INRATIO/INRATIO2 TEST STRIPS
K092987 · GJS
Biosite Incorporated
Hematology · 256d
Cleared Apr 19, 2010
ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP
K092048 · DJR
Biosite Incorporated
Chemistry · 286d
Cleared Nov 13, 2009
TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET
K093032 · JJY
Biosite Incorporated
Chemistry · 45d
Cleared Jun 06, 2008
TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS
K080269 · NBC
Biosite Incorporated
Chemistry · 126d
Cleared Dec 07, 2007
TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5
K072892 · JJY
Biosite Incorporated
Chemistry · 58d
Cleared Mar 01, 2007
TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS
K062840 · GGN
Biosite Incorporated
Hematology · 160d
Cleared Jan 29, 2007
TRIAGE PROTEIN C TEST
K062530 · GGP
Biosite Incorporated
Hematology · 153d
Cleared Jul 10, 2006
TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414
K060788 · DIF
Biosite Incorporated
Chemistry · 109d
Cleared Jun 22, 2006
TRIAGE TOX DRUG SCREEN, MODEL 94400
K060791 · DJR
Biosite Incorporated
Toxicology · 91d
Cleared Jan 23, 2006
TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200
K052789 · NBC
Biosite Incorporated
Chemistry · 112d
Cleared Sep 22, 2005
TRIAGE BNP TEST, MODEL 98000XR
K051787 · NBC
Biosite Incorporated
Chemistry · 83d
Cleared Jun 29, 2005
TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS
K050799 · GGN
Biosite Incorporated
Hematology · 91d
Cleared Mar 22, 2005
TRIAGE TOX DRUG SCREEN CONTROLS
K050037 · DIF
Biosite Incorporated
Chemistry · 74d
Cleared Feb 28, 2005
TRIAGE TOX DRUG SCREEN
K043242 · LDP
Biosite Incorporated
Toxicology · 97d
Cleared Dec 07, 2004
TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300
K042723 · DAP
Biosite Incorporated
Chemistry · 67d
Cleared Nov 29, 2004
TRIAGE D-DIMER TEST, MODEL 98100
K042890 · GHH
Biosite Incorporated
Hematology · 41d
Cleared Jul 06, 2004
TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS
K040459 · JJY
Biosite Incorporated
Chemistry · 134d
Cleared Jun 25, 2004
TRIAGE PROFILER S.O.B. PANEL
K040437 · DAP
Biosite Incorporated
Chemistry · 127d
Cleared Jan 28, 2004
MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
K032235 · NBC
Biosite Incorporated
Chemistry · 191d
Cleared Dec 23, 2003
TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG...
K033383 · NBC
Biosite Incorporated
Chemistry · 61d
Cleared Feb 21, 2003
TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL
K030286 · NBC
Biosite Incorporated
Chemistry · 24d
Cleared Jan 23, 2003
TRIAGE CARDIAC CONTROLS
K030089 · JJY
Biosite Incorporated
Chemistry · 13d
Cleared Jan 17, 2003
TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER...
K030088 · JJY
Biosite Incorporated
Chemistry · 7d