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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nadh Oxidation/Nad Reduction, Alt/Sgpt
510(k) Number K760194
Device Name NDC#12739-0010-1 C-ZYME GPT
Applicant
Coulter Electronics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Coulter Electronics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1030
Classification Product Code
CKA  
Date Received07/06/1976
Decision Date 08/03/1976
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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