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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
Rte. 70 E.
Mishawaka,  IN  46546
Applicant Contact ROSANNE M SAVOL
Correspondent
Bayer Corp.
P.O. Box 2004
Rte. 70 E.
Mishawaka,  IN  46546
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
Predetermined Change
Control Plan Authorized		 No
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