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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 K871976
Device Name MULTICHEM GLUCOSE HEXOKINASE REAGENT #S0919
Applicant
Simmler, Inc.
Post Office Box 25179
St. Louis,  MO  63125
Applicant Contact KAREN E TIDD
Correspondent
Simmler, Inc.
Post Office Box 25179
St. Louis,  MO  63125
Correspondent Contact KAREN E TIDD
Regulation Number862.1345
Classification Product Code
CFR  
Date Received05/22/1987
Decision Date 06/05/1987
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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