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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 K893404
Device Name INTEGRA(TM) BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Apprise, Inc.
5000 Old Ironsides Dr.
Santa Clara,  CA  95054
Applicant Contact RODGER J RICHEAL
Correspondent
Apprise, Inc.
5000 Old Ironsides Dr.
Santa Clara,  CA  95054
Correspondent Contact RODGER J RICHEAL
Regulation Number862.1345
Classification Product Code
CGA  
Date Received05/02/1989
Decision Date 08/03/1989
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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