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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K024234
Device Name ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL
Applicant
Bayer Corp.
1884 Miles Ave.
P.O. Box 70
Elkhart,  IN  46514 -0070
Applicant Contact GEORGE M TANCOS
Correspondent
Bayer Corp.
1884 Miles Ave.
P.O. Box 70
Elkhart,  IN  46514 -0070
Correspondent Contact GEORGE M TANCOS
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
JQP  
Date Received12/23/2002
Decision Date 01/23/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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