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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 K951537
Device Name GLUCOMETER ELITE M BLOOD GLUCOSE METER
Applicant
BAYER CORP.
P.O. BOX 2004
ROUTE 70 EAST
MISHAWAKA,  IN  46546 -2004
Applicant Contact ROSANNE M SAVOL
Correspondent
BAYER CORP.
P.O. BOX 2004
ROUTE 70 EAST
MISHAWAKA,  IN  46546 -2004
Correspondent Contact ROSANNE M SAVOL
Regulation Number862.1345
Classification Product Code
CGA  
Date Received04/03/1995
Decision Date 07/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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