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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 K964946
Device Name SYSMEX CA-1000/SYSMEX CA-5000
Applicant
Sysmex Corp.
Gilmer Rd.
6699 Rfd
Long Grove,  IL  60047
Applicant Contact MARGARET BARRANCO, MA, MT (ASCP)
Correspondent
Sysmex Corp.
Gilmer Rd.
6699 Rfd
Long Grove,  IL  60047
Correspondent Contact MARGARET BARRANCO, MA, MT (ASCP)
Regulation Number864.5425
Classification Product Code
JPA  
Date Received12/10/1996
Decision Date 03/18/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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