FDA 510(k) Applications for Medical Device:
Electrode, Ion-Specific, Chloride

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K991870 A.P. TOTAL CARE, INC. 70 HAWLEY AVE,
BRIDGEPORT CT
K980367 ABBOTT LABORATORIES 1920 HURD DRIVE
IRVING TX 75038
K170320 Abbott Laboratories Dept. 09AA, Bldg CP01-3, 100 Abbott Park Road
Abbott Park IL 60064
K963734 ALKO DIAGNOSTIC CORP. 333 FISKE ST.
HOLLISTON MA 01746
K972004 ALKO DIAGNOSTIC CORP. 333 FISKE ST.
HOLLISTON MA 01746
K981270 DIAMETRICS MEDICAL, INC. 2658 PATTON RD.
SAINT PAUL MN 55113
K980757 INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE.
LEXINGTON MA 02173
K963992 MEDICA CORP. 14 DEANGELO DR.
BEDFORD MA 01730
K000926 MEDICA CORP. 14 DEANGELO DR.
BEDFORD MA 01730
K162020 Ortho Clinical Diagnostics 100 Indigo Creek Drive
Rochester NY 14626
K082099 Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR.
ROCHESTER NY 14626-5101
K182072 Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive
Rochester NY 14626
K052027 OSMETECH, INC. 235 HEMBREE PARK DRIVE
ROSWELL GA 30076
K020148 PHOENIX DIAGNOSTICS, INC. 8 TECH CIRCLE
NATICK MA 01760
K013451 PHOENIX DIAGNOSTICS, INC. 8 TECH CIRCLE
NATICK MA 01760
K060108 ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD.
INDIANAPOLIS IN 46250
K973742 SENDX MEDICAL, INC. 1945 PALOMAR OAKS WAY
CARLSBAD CA 92011
K962479 SYNERMED, INC. 1688 50TH AVENUE,
QUEBEC, CANADA H8T 2V5
K070531 Thermo Fisher Scientific 171 INDUSTRY DRIVE
PITTSBURGH PA 15275
K003668 WALLAC OY MUSTIONKATU 6
TURKU 20750
K070889 WALLAC OY MUSTIONKATU 6
TURKU 20750
K993697 WALLAC OY MUSTIONKATU 6
TURKU 20750
K003664 WALLAC OY MUSTIONKATU 6
TURKU 20750




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