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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
510(k) Number K051564
Device Name OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH
Applicant
Olympus America, Inc.
3131 W. Royal Ln.
Irving,  TX  75063 -3104
Applicant Contact BEV HARDING
Correspondent
Olympus America, Inc.
3131 W. Royal Ln.
Irving,  TX  75063 -3104
Correspondent Contact BEV HARDING
Regulation Number866.5270
Classification Product Code
NQD  
Subsequent Product Code
JIT  
Date Received06/14/2005
Decision Date 08/22/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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