Stanbio Laboratory

FDA 510(k) & PMA Approved Devices — 47 products

Total Devices47

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K090093	STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM	GKR	2009-06-10	View
510(k)	K081719	STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM	GKR	2008-07-18	View
510(k)	K050283	CREATININE LIQUICOLOR	JFY	2005-06-30	View
510(k)	K050266	DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR	JFM	2005-06-30	View
510(k)	K042169	STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER	JJE	2005-03-14	View
510(k)	K041155	WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY	DCK	2004-10-14	View
510(k)	K032936	DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR	JIX	2004-03-12	View
510(k)	K032932	DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR	LBS	2004-03-10	View
510(k)	K032482	STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM	GKR	2003-10-24	View
510(k)	K020378	QUPID PLUS E.R.	JHI	2002-06-21	View
510(k)	K974429	RAPET CRP	DCN	1998-02-18	View
510(k)	K974370	RAPET RF	DHR	1998-02-17	View
510(k)	K972155	CREATINE KINASE (CK)	CGS	1997-07-17	View
510(k)	K962418	UREA NITROGEN (BUN) LIQUI-UV	CDQ	1996-12-26	View
510(k)	K941314	STANBIO ALT/GPT (LUQUI-UV) TEST SET	CKA	1994-07-20	View
510(k)	K941315	STANBIO Y-GT (LIQUICOLOR) TEST SET	JQB	1994-07-14	View
510(k)	K941313	STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET	CJE	1994-05-17	View
510(k)	K932049	STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020	CIT	1993-11-16	View
510(k)	K902204	STANBIO CSF/URINE TOTAL PROTEIN TEST SET	JIR	1990-08-22	View
510(k)	K893128	STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010	CDL	1989-07-25	View