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

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K093318 ABBOTT LABORATORIES 1920 HURD DRIVE
IRVING TX 75038
K993083 ABBOTT LABORATORIES DEPT. 09VA LC-2
IRVING TX 75038
K974784 AVL SCIENTIFIC CORP. 33 MANSELL COURT
ROSWELL GA 30076-4807
K112412 BECKMAN COULTER, INC. 250 S. KRAEMER BOULEVARD
BREA CA 92821
K042291 BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD.,W-104
BREA CA 92822-8000
K040750 CLINICAL ANALYSIS CORPORATION, INC. 2100 QUAKER POINTE DRIVE
QUAKERTOWN PA 18951-2182
K010061 DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY;
P.O. BOX 6101, NEWARK DE 19714-6101
K970330 DADE INTL., INC. BUILDING 500, MAILBOX 514
NEWARK DE 19714-6101
K200544 Diamond Diagnostics Inc. 333 Fiske Street
Holliston MA 01746
K121040 DIAMOND DIAGNOSTICS, INC. 333 FISKE ST.
HOLLISTON MA 01746
K092849 EPOCAL, INC. 2060 WALKLEY RD.
OTTAWA, ONTARIO K1G-3P5
K121012 INPECO S.P.A. 11 VIA G. DI VITTORIO
SEGRATE, MILAN 20090
K112995 INSTRUMENTATION LABORATORY CO. 526 ROUTE 303
ORANGEBURG NY 10962
K961115 JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR.
ROCHESTER NY 14650-0882
K112788 MEDICA CORP. 5 OAK PARK DRIVE
BEDFORD MA 01730
K961326 MEDICA CORP. 14 DEANGELO DR.
BEDFORD MA 01730
K220396 Medica corporation 5 Oak Park Drive
Bedford MA 01730
K073157 Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR.
ROCHESTER NY 14626-5101
K083680 Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR.
ROCHESTER NY 14626-5101
K061730 OSMETECH, INC. 235 HEMBREE PARK DRIVE
ROSWELL GA 30076
K112408 POLYMEDCO, INC. 510 FURNACE DOCK RD.
CORTLANDT MANOR NY 10567
K092686 RADIOMETER MEDICAL APS AKANDEVEJ 21
BRONSHOJ DK-2700
K230890 Randox Laboratories Ltd. 55 Diamond Road
Crumlin BT29 4QY
K052914 RANDOX LABORATORIES, LTD. 55 DIAMOND RD.
CRUMLIN, COUNTY ANTRIM BT29 4QY
K060373 Roche Diagnostics 9115 HAGUE ROAD
INDIANAPOLIS IN 46250-0416
K013373 ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD.
INDIANAPOLIS IN 46250
K032311 ROCHE DIAGNOSTICS CORP. P.O. BOX 50457
INDIANAPOLIS IN 46250-0457
K042270 STAT CHEM, INC. 619 NORTH POPLAR STREET
ORANGE CA 92868
K061107 THERMO ELECTRON OY RATASTIE 2
VANTAA 01620
K110520 TOKYO BOEKI MEDISYS INC. 5105 FAIROAKS ROAD
DURHAM NC 27712




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