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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Automated Platelet Aggregation
510(k) Number K041502
FOIA Releasable 510(k) K041502
Device Name THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY
Applicant
Haemoscope Corp.
5693 W. Howard
Niles,  IL  60714
Applicant Contact ELI COHEN
Correspondent
Haemoscope Corp.
5693 W. Howard
Niles,  IL  60714
Correspondent Contact ELI COHEN
Regulation Number864.5700
Classification Product Code
JOZ  
Date Received06/07/2004
Decision Date 09/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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