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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Method, Immunodiffusion, Immunoglobulins (G, A, M)
510(k) Number K920006
Device Name IL TEST IMMUNOGLOBULIN G (IGG)
Applicant
Instrumentation Laboratory CO
113 Hartwell Ave.
P.O. Box 9113
Lexington,  MA  02173
Applicant Contact MURACA, JR.
Correspondent
Instrumentation Laboratory CO
113 Hartwell Ave.
P.O. Box 9113
Lexington,  MA  02173
Correspondent Contact MURACA, JR.
Regulation Number866.5510
Classification Product Code
CGM  
Date Received01/02/1992
Decision Date 03/13/1992
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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