FDA 510(k) Applications for Medical Device: Enzyme Controls (Assayed And Unassayed)

FDA 510(k) Applications for Medical Device:
Enzyme Controls (Assayed And Unassayed)

FDA 510(k) Number	Applicant	Address	City / Country	State / Province	Postal Code
K090940	ASTORIA-PACIFIC,INC.	15130 S.E. 82ND DR.	CLACKAMAS	OR	97015
K030102	BAYER HEALTHCARE, LLC	511 BENEDICT AVE.	TARRYTOWN	NY	10591
K960275	BEHRING DIAGNOSTICS, INC.	151 UNIVERSITY AVE.	WESTWOOD	MA	02090
K961828	BIO-RAD	3726 EAST MIRALOMA AVE.	ANAHEIM	CA	92806
K980556	BIO-RAD	9500 JERONIMO RD.	IRVINE	CA	92618-2017
K021498	BIO-RAD	9500 JERONIMO RD.	IRVINE	CA	92618
K012656	BIO-RAD	9500 JERONIMO RD.	IRVINE	CA	92618-2017
K974461	BIOSITE INCORPORATED	11030 ROSELLE ST.	SAN DIEGO	CA	92121
K960246	CIBA CORNING DIAGNOSTICS CORP.	333 CONEY ST.	E. WALPOLE	MA	02032
K030768	CLINIQA CORPORATION	1432 SOUTH MISSION RD.	FALLBROOK	CA	92028
K973974	DADE INTL., INC.	2173 NW 99TH AVE.	MIAMI	FL	33172
K971777	INSTRUMENTATION LABORATORY CO.	113 HARTWELL AVE.	LEXINGTON	MA	02173
K984437	INSTRUMENTATION LABORATORY CO.	180 HARTWELL ROAD	BEDFORD	MA	01730
K984277	MEDICAL ANALYSIS SYSTEMS, INC.	542 FLYNN RD.	CAMARILLO	CA	93012-8058
K992430	MEDICAL ANALYSIS SYSTEMS, INC.	542 FLYNN RD.	CAMARILLO	CA	93012-8058
K970856	MEDICAL ANALYSIS SYSTEMS, INC.	542 FLYNN RD.	CAMARILLO	CA	93012-8058
K972976	MORE DIAGNOSTICS	2020 11TH ST.	LOS OSOS	CA	93402
K982845	MORE DIAGNOSTICS	2020 11TH ST.	LOS OSOS	CA	93402
K993723	QUANTIMETRIX CORP.	2005 MANHATTAN BEACH BLVD.	REDONDO BEACH	CA	90278-1205
K062751	QUANTIMETRIX CORP.	2005 MANHATTAN BEACH BLVD.	REDONDO BEACH	CA	90278-1205
K993715	SERACARE TECHNOLOGY	2170 WOODWARD ST.	AUSTIN	TX	78744-1832
K965168	SPECIALIZED ASSAYS, INC.	P.O. BOX 60	PIPERSVILLE	PA	18947
K965169	SPECIALIZED ASSAYS, INC.	P.O. BOX 60	PIPERSVILLE	PA	18947
K965166	SPECIALIZED ASSAYS, INC.	P.O. BOX 60	PIPERSVILLE	PA	18947
K972408	SPECTRAL DIAGNOSTICS, INC.	135-2 THE WEST MALL	TORONTO, ONTARIO		M9C1C2