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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Multipurpose For In Vitro Coagulation Studies
510(k) Number K942096
Device Name TOA MEDICAL ELECTRONICS CA-1000
Applicant
Sysmex Corp.
4410 Cerritos Ave.
Los Alamitos,  CA  90720
Applicant Contact JEME WALLACE
Correspondent
Sysmex Corp.
4410 Cerritos Ave.
Los Alamitos,  CA  90720
Correspondent Contact JEME WALLACE
Regulation Number864.5425
Classification Product Code
JPA  
Date Received04/14/1994
Decision Date 03/24/1995
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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