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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diazo, Ast/Sgot
510(k) Number K881173
Device Name ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD)
Applicant
Tech-Co, Inc.
24111 Beverly
Oak Park,  MI  48237
Applicant Contact CHEN, PHD
Correspondent
Tech-Co, Inc.
24111 Beverly
Oak Park,  MI  48237
Correspondent Contact CHEN, PHD
Regulation Number862.1100
Classification Product Code
CIQ  
Date Received03/18/1988
Decision Date 06/07/1988
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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