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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Haptoglobin, Antigen, Antiserum, Control
510(k) Number K915829
Device Name IL TEST(TM) HAPTOGLOBIN (HPT)
Applicant
Instrumentation Laboratory CO
113 Hartwell Ave.
P.O. Box 9113
Lexington,  MA  02173
Applicant Contact GABRIEL J MURACA
Correspondent
Instrumentation Laboratory CO
113 Hartwell Ave.
P.O. Box 9113
Lexington,  MA  02173
Correspondent Contact GABRIEL J MURACA
Regulation Number866.5460
Classification Product Code
DAD  
Date Received12/30/1991
Decision Date 07/29/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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