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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hydrazone Colorimetry, Ast/Sgot
510(k) Number K812872
Device Name OPTIONAL TOTAL CA-MODULE FOR IL 504/508
Applicant
Instrumentation Laboratory CO
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Instrumentation Laboratory CO
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1100
Classification Product Code
CIS  
Date Received10/14/1981
Decision Date 10/26/1981
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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