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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 K761345
Device Name GLUCO-HEX TM REAGENT KIT
Applicant
J.T. Baker Chemical Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
J.T. Baker Chemical Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1345
Classification Product Code
CFR  
Date Received12/28/1976
Decision Date 01/05/1977
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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