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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 K913806
Device Name YSI MODEL 2300 STAT PLUS
Applicant
Ysis, Inc.
1725 Brannum Ln.
Yellow Springs,  OH  45387
Applicant Contact FRED BREIDT
Correspondent
Ysis, Inc.
1725 Brannum Ln.
Yellow Springs,  OH  45387
Correspondent Contact FRED BREIDT
Regulation Number862.1345
Classification Product Code
CGA  
Date Received08/26/1991
Decision Date 10/02/1991
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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