FDA 510(k) Applications for Medical Device:
Cardiac C-Reactive Protein, Antigen, Antiserum, And Control

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K071002 BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD.
BREA CA 92822-8000
K070626 BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD.
BREA CA 92821
K053109 DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY;
NEWARK DE 19714-6101
K061802 DADE BEHRING, INC. P.O. BOX 6101
NEWARK DE 19714-6101
K033908 DADE BEHRING, INC. GLASGOW SITE
NEWARK DE 19714-6101
K060369 DADE BEHRING, INC. PO BOX 6101
NEWARK DE 19714-6101
K062924 DADE BEHRING, INC. P.O. BOX 6101 BLDG 500;M.S.514
NEWARK DE 19714-6101
K063057 DIAGNOSTIC PRODUCTS CORPORATION 5210 PACIFIC CONCOURSE DR
LOS ANGELES CA 90045-6900
K041668 OLYMPUS AMERICA INC. 3131 W. ROYAL LANE
IRVING TX 75063-3104
K051564 OLYMPUS AMERICA, INC. 3131 WEST ROYAL LN.
IRVING TX 75063-3104
K041799 Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR.
ROCHESTER NY 14626-5101
K053603 ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD.
INDIANAPOLIS IN 46250
K042485 ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD.
INDIANAPOLIS IN 46250
K173833 SENTINEL CH. SpA Via Robert Koch 2
Milano 20152
K081294 Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE.
TARRYTOWN NY 10591
K212559 Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring Str. 76
Marburg 35041
K071017 SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR.
LOS ANGELES CA 90045-6900




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