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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 K000102
Device Name GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150
Applicant
TECO DIAGNOSTICS
4925 EAST HUNTER AVE.
ANAHEIM,  CA  92807
Applicant Contact DINDO CARRILLO
Correspondent
TECO DIAGNOSTICS
4925 EAST HUNTER AVE.
ANAHEIM,  CA  92807
Correspondent Contact DINDO CARRILLO
Regulation Number862.1345
Classification Product Code
CFR  
Date Received01/13/2000
Decision Date 02/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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