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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name acid, uric, uricase (u.v.)
510(k) Number K955752
Device Name OLYMPUS URIC ACID REAGENT
Applicant
OLYMPUS AMERICA, INC.
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -3157
Applicant Contact LAURA STORMS-TYLER
Correspondent
OLYMPUS AMERICA, INC.
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -3157
Correspondent Contact LAURA STORMS-TYLER
Regulation Number862.1775
Classification Product Code
CDO  
Date Received12/19/1995
Decision Date 01/31/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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