Pointe Scientific, Inc.,

FDA 510(k) & PMA Approved Devices — 74 products

Total Devices74

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Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K070757	MICROPROTEIN REAGENT SET	JGP	2007-12-04	View
510(k)	K062118	POINTE 360	CFR	2007-07-13	View
510(k)	K070251	CARBON DIOXIDE LIQUID STABLE REAGENT	KHS	2007-04-30	View
510(k)	K070207	MULTI-ANALYTE CHEMISTRY CALIBRATOR	JIX	2007-04-13	View
510(k)	K070504	AMMONIA/ALCOHOL CONTROL SET	JJY	2007-04-11	View
510(k)	K061377	APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS	MSJ	2007-03-28	View
510(k)	K051646	ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH	JGS	2005-10-07	View
510(k)	K040391	TOTAL BILIRUBIN REAGENT SET	CIG	2004-06-02	View
510(k)	K031539	HEMOGLOBIN A1C REAGENT SET	LCP	2003-08-06	View
510(k)	K023860	MICROALBUMIN REAGENT SET AND CALIBRATORS	DDZ	2003-04-28	View
510(k)	K024006	G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE	JBF	2003-03-31	View
510(k)	K023396	AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)	CIJ	2002-12-23	View
510(k)	K002199	MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET	CFR	2000-11-20	View
510(k)	K002651	C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET	DCK	2000-10-13	View
510(k)	K993590	FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET	LCP	1999-12-21	View
510(k)	K992002	AUTOHDL CHOLESTEROL REAGENT SET	LBR	1999-08-05	View
510(k)	K981978	AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR	MRR	1998-07-22	View
510(k)	K973588	LIQUID ALKALINE PHOSHATASE REAGENT SET	CJE	1997-10-22	View
510(k)	K973157	LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET	JQB	1997-10-10	View
510(k)	K973589	LIQUID LDH-L REAGENT SET	CFJ	1997-10-08	View