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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Fibrinogen
510(k) Number K923921
Device Name IL TEST PT FIBRINOGEN HS
Applicant
INSTRUMENTATION LABORATORY CO.
113 HARTWELL AVE.
P.O. BOX 9113
LEXINGTON,  MA  02173
Applicant Contact WALLIS W CADY
Correspondent
INSTRUMENTATION LABORATORY CO.
113 HARTWELL AVE.
P.O. BOX 9113
LEXINGTON,  MA  02173
Correspondent Contact WALLIS W CADY
Regulation Number864.7340
Classification Product Code
GIS  
Date Received08/05/1992
Decision Date 10/26/1992
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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