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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, Ast/Sgot
510(k) Number K781784
Device Name AST
Applicant
GILFORD DIAGNOSTICS
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
GILFORD DIAGNOSTICS
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1100
Classification Product Code
CIT  
Date Received10/19/1978
Decision Date 01/03/1979
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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