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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Fibrinogen Determination
510(k) Number K931721
Device Name IL TEST FIBRINOGEN-C
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
KQJ  
Date Received04/07/1993
Decision Date 08/13/1993
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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