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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 K891050
Device Name STAT CHEM SYSTEM
Applicant
Diagnostic Resources, Inc.
375 Central Ave.
Bohemia,  NY  11716
Applicant Contact RINALDO PAGNUCCO,PHD
Correspondent
Diagnostic Resources, Inc.
375 Central Ave.
Bohemia,  NY  11716
Correspondent Contact RINALDO PAGNUCCO,PHD
Regulation Number862.1345
Classification Product Code
CGA  
Date Received02/28/1989
Decision Date 07/20/1989
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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