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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diazo Colorimetry, Bilirubin
510(k) Number K850748
Device Name I-L TEST, DIRECT BILIRUBIN SET
Applicant
Allied Instrumentation Laboratory
113 Hartwell Ave.
Lexington,  MA  02173
Applicant Contact GEORGE A LYNA
Correspondent
Allied Instrumentation Laboratory
113 Hartwell Ave.
Lexington,  MA  02173
Correspondent Contact GEORGE A LYNA
Regulation Number862.1110
Classification Product Code
CIG  
Date Received02/25/1985
Decision Date 04/03/1985
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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