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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
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