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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hexokinase, Glucose
510(k) Number K944406
Device Name OLYMPUS GLUCOSE REAGENT
Applicant
Olympus America, Inc.
4 Nevada Dr.
Lake Success,  NY  11042 -1179
Applicant Contact LAURA STORMS-TYLER
Correspondent
Olympus America, Inc.
4 Nevada Dr.
Lake Success,  NY  11042 -1179
Correspondent Contact LAURA STORMS-TYLER
Regulation Number862.1345
Classification Product Code
CFR  
Date Received09/08/1994
Decision Date 03/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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