Biosite Incorporated

FDA 510(k) & PMA Approved Devices — 45 products

Total Devices45

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K092987	INRATIO/INRATIO2 TEST STRIPS	GJS	2010-06-11	View
510(k)	K092048	ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP	DJR	2010-04-19	View
510(k)	K093032	TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET	JJY	2009-11-13	View
510(k)	K080269	TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS	NBC	2008-06-06	View
510(k)	K072892	TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5	JJY	2007-12-07	View
510(k)	K062840	TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS	GGN	2007-03-01	View
510(k)	K062530	TRIAGE PROTEIN C TEST	GGP	2007-01-29	View
510(k)	K060788	TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414	DIF	2006-07-10	View
510(k)	K060791	TRIAGE TOX DRUG SCREEN, MODEL 94400	DJR	2006-06-22	View
510(k)	K052789	TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200	NBC	2006-01-23	View
510(k)	K051787	TRIAGE BNP TEST, MODEL 98000XR	NBC	2005-09-22	View
510(k)	K050799	TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS	GGN	2005-06-29	View
510(k)	K050037	TRIAGE TOX DRUG SCREEN CONTROLS	DIF	2005-03-22	View
510(k)	K043242	TRIAGE TOX DRUG SCREEN	LDP	2005-02-28	View
510(k)	K042723	TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300	DAP	2004-12-07	View
510(k)	K042890	TRIAGE D-DIMER TEST, MODEL 98100	GHH	2004-11-29	View
510(k)	K040459	TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS	JJY	2004-07-06	View
510(k)	K040437	TRIAGE PROFILER S.O.B. PANEL	DAP	2004-06-25	View
510(k)	K032235	MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST	NBC	2004-01-28	View
510(k)	K033383	TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200	NBC	2003-12-23	View