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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Coagulation, Automated
510(k) Number K895844
Device Name THROMBELASTOGRAPH(R)
Applicant
Haemoscope Corp.
5836 Lincoln Ave.
Morton Grove,  IL  60053
Applicant Contact ZUCKERMAN, PHD
Correspondent
Haemoscope Corp.
5836 Lincoln Ave.
Morton Grove,  IL  60053
Correspondent Contact ZUCKERMAN, PHD
Regulation Number864.5400
Classification Product Code
GKP  
Date Received10/03/1989
Decision Date 10/24/1989
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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