FDA 510(k) Applications for Medical Device:
Urease, Photometric, Urea Nitrogen

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K113389 ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. 4 HENDERSON DRIVE
WEST CALDWELL NJ 07006
K103615 ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. 4 HENDERSON DRIVE
WEST CALDWELL NJ 07006
K123322 ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC 4 HENDERSON DRIVE
WEST CALDWELL NJ 07006
K792328 BOEHRINGER MANNHEIM CORP.
K972012 CHOLESTECH CORP. 3347 INVESTMENT BLVD.
HAYWARD CA 94545
K781253 COULTER ELECTRONICS, INC.
K914903 EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD.
GIBBSTOWN NJ 08027
K132462 HITACHI CHEMICAL DIAGNOSTICS, INC. 575 Shirlynn Court
Los Altos CA 94022
K771442 INSTRUMENTATION LABORATORY CO.
K961196 JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR.
ROCHESTER NY 14650-0882
K922969 KING DIAGNOSTICS, INC. 6856 HAWTHORN PARK DR.
INDIANAPOLIS IN 46220
K802518 NOBEL SCIENTIFIC INDUSTRIES, INC.
K001885 Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR.
ROCHESTER NY 14626-5101
K943042 PRISMA SYSTEMS 1721 BLACK RIVER BLVD.
ROME NY 13440
K822154 THE DOW CHEMICAL CO.




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