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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 K862302
Device Name BLOOD PLATELET ASSAY METHOD & APPARATUS
Applicant
Bellhouse Medical, Inc.
International Sq.
1825 Eye St. NW, Suite 400
Washington,  DC  20006
Applicant Contact RICHARD T NEY
Correspondent
Bellhouse Medical, Inc.
International Sq.
1825 Eye St. NW, Suite 400
Washington,  DC  20006
Correspondent Contact RICHARD T NEY
Regulation Number864.5700
Classification Product Code
JOZ  
Date Received06/17/1986
Decision Date 07/31/1986
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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