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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Thrombin Time
510(k) Number K862301
Device Name IL SYSTEM 810, ACL AND THE REAGENT SETS
Applicant
Instrumentation Laboratory CO
113 Hartwell Ave.
P.O. Box 9113
Lexington,  MA  02173
Applicant Contact GEORGE A LYNA
Correspondent
Instrumentation Laboratory CO
113 Hartwell Ave.
P.O. Box 9113
Lexington,  MA  02173
Correspondent Contact GEORGE A LYNA
Regulation Number864.7875
Classification Product Code
GJA  
Date Received06/17/1986
Decision Date 09/03/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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