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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Oxidase, Glucose
510(k) Number K875049
Device Name MD STRIPS BG
Applicant
AMATECH INTERNATIONAL, INC.
2400 CENTRAL PARKWAY, STE. K
HOUSTON,  TX  77092
Applicant Contact DURBIN, PHD
Correspondent
AMATECH INTERNATIONAL, INC.
2400 CENTRAL PARKWAY, STE. K
HOUSTON,  TX  77092
Correspondent Contact DURBIN, PHD
Regulation Number862.1345
Classification Product Code
CGA  
Date Received12/09/1987
Decision Date 08/23/1988
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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