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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 K874846
Device Name GLUCOSE (HEXOKINASE)
Applicant
TECH-CO, INC.
24111 BEVERLY
OAK PARK,  MI  48237
Applicant Contact HAPPY CHEN
Correspondent
TECH-CO, INC.
24111 BEVERLY
OAK PARK,  MI  48237
Correspondent Contact HAPPY CHEN
Regulation Number862.1345
Classification Product Code
CFR  
Date Received11/24/1987
Decision Date 03/03/1988
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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