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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
Original Applicant
BAYER CORP.
1884 miles ave.
p.o. box 70
elkhart,  IN  46514 -0070
Original 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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