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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 K844322
Device Name SGOT REAGENT SET
Applicant
Livonia Diagnostics, Inc.
33041 W. Eight Mile Rd.
Livonia,  MI  48152
Applicant Contact WALTER H LAMBERT
Correspondent
Livonia Diagnostics, Inc.
33041 W. Eight Mile Rd.
Livonia,  MI  48152
Correspondent Contact WALTER H LAMBERT
Regulation Number862.1100
Classification Product Code
CIQ  
Date Received11/07/1984
Decision Date 11/27/1984
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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