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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Azo Dye, Calcium
510(k) Number K061575
Device Name OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117
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 Number862.1145
Classification Product Code
CJY  
Date Received06/07/2006
Decision Date 10/05/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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