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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 K933252
Device Name IL TEST (TM) PT-FIBRINOGEN HS PLUS
Applicant
Instrumentation Laboratory CO
180 Hartwell Rd.
Bedford,  MA  01730
Applicant Contact WALLIS W CADY
Correspondent
Instrumentation Laboratory CO
180 Hartwell Rd.
Bedford,  MA  01730
Correspondent Contact WALLIS W CADY
Regulation Number864.7750
Classification Product Code
GJS  
Subsequent Product Code
GIS  
Date Received07/02/1993
Decision Date 10/04/1993
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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