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

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K103387 ACON LABORATORIES, INC. 10125 MESA RIM RD.
SAN DIEGO CA 92121
K052242 BAYER HEALTHCARE LLC 511 BENEDICT AVE.
TARRYTOWN NY 10591
K031231 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618-2017
K000874 BIO-RAD 9500 JERONIMO RD.
IRVINE CA 92618-2017
K042446 BIO-RAD LABORATORIES, INC. 9500 JERONIMO RD.
IRVINE CA 92618-2017
K070848 BIO-RAD, DIAGNOSTICS GRP. 9500 JERONIMO RD.
IRVINE CA 92618-2017
K081908 CLINIQA CORPORATION 774 N. TWIN OAKS VALLEY RD.
SAN MARCOS CA 92069
K992576 CONSOLIDATED TECHNOLOGIES, INC. 2170 WOODWARD STREET, STE. 100
AUSTIN TX 78744-1832
K992578 CONSOLIDATED TECHNOLOGIES, INC. 2170 WOODWARD STREET, STE. 100
AUSTIN TX 78744-1832
K972710 HEMATRONIX, INC. 524 STONE RD.
BENICIA CA 94510
K072640 IRIS DIAGNOSTICS 9172 ETON AVE.
CHATSWORTH CA 91311
K022085 J & S MEDICAL ASSOC., INC. 35 TRIPP ST., BLDG. #1
FRAMINGHAM MA 01702
K973451 MEDICAL ANALYSIS SYSTEMS, INC. 542 FLYNN RD.
CAMARILLO CA 93012-8058
K023928 MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD.
CAMARILLO CA 93012
K021155 MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD.
CAMARILLO CA 93012
K981933 MEDICAL ANALYSIS SYSTEMS, INC. 542 FLYNN RD.
CAMARILLO CA 93012-8058
K031441 MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD.
CAMARILLO CA 93012
K991917 METRIKA, INC. 510 OAKMEAD PKWY.
SUNNYVALE CA 94085-4022
K142262 QUANTIMETRIX CORP. 2005 MANHATTAN BEACH BLVD.
REDONDO BEACH CA 90278-1205
K110846 RANDOX LABORATORIES LIMITED 55 DIAMOND ROAD CRUMLIN
CRUMLIN ANTRIM BT29 4QY
K043266 RANDOX LABORATORIES, LTD. 55 DIAMOND RD.
CRUMLIN, COUNTY ANTRIM BT29 4QY
K170091 Streck 7002 S. 109th Street
La Vista NE 68128
K131444 Streck 7002 SOUTH 109TH ST.
OMAHA NE 68128




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