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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 K864322
Device Name MPX SYSTEM, GLUCOSE TEST SYSTEM
Applicant
Lifescan, Inc.
2443 Wyandotte St.
Mountain View,  CA  94043
Applicant Contact DUFF SELF
Correspondent
Lifescan, Inc.
2443 Wyandotte St.
Mountain View,  CA  94043
Correspondent Contact DUFF SELF
Regulation Number862.1345
Classification Product Code
CGA  
Date Received11/03/1986
Decision Date 02/25/1987
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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