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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 K915772
Device Name DIASCAN BLOOD GLUCOSE MONITORING TEST STRIP
Applicant
HOME DIAGNOSTICS, INC.
51 JAMES WAY
EATONTOWN,  NJ  07724
Applicant Contact Maureen Garner
Correspondent
HOME DIAGNOSTICS, INC.
51 JAMES WAY
EATONTOWN,  NJ  07724
Correspondent Contact Maureen Garner
Regulation Number862.1345
Classification Product Code
CGA  
Date Received12/24/1991
Decision Date 04/14/1992
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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