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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Time, Prothrombin
510(k) Number K931118
Device Name ASSESS(TM) HIGH ABNORMAL CONTROL
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 Number864.7750
Classification Product Code
GJS  
Date Received03/04/1993
Decision Date 03/30/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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