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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 K092506
Device Name EASYRA GLU-H REAGENT, MODEL 10200
Applicant
MEDICA CORP.
5 OAK PARK DRIVE
BEDFORD,  MA  01730
Applicant Contact Photios Makris
Correspondent
MEDICA CORP.
5 OAK PARK DRIVE
BEDFORD,  MA  01730
Correspondent Contact Photios Makris
Regulation Number862.1345
Classification Product Code
CFR  
Date Received08/17/2009
Decision Date 09/16/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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