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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antithrombin Iii Quantitation
510(k) Number K980499
Device Name IL TEST ANTITHROMBIN
Applicant
Instrumentation Laboratory CO
113 Hartwell Ave.
Lexington,  MA  02173
Applicant Contact CAROL MARBLE
Correspondent
Instrumentation Laboratory CO
113 Hartwell Ave.
Lexington,  MA  02173
Correspondent Contact CAROL MARBLE
Regulation Number864.7060
Classification Product Code
JBQ  
Date Received02/09/1998
Decision Date 04/02/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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