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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 K810993
Device Name GLUCOSCAN TEST STRIPS
Applicant
Lifescan, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Lifescan, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1345
Classification Product Code
CGA  
Date Received04/13/1981
Decision Date 04/29/1981
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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