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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Differential Cell
510(k) Number K943894
Device Name SYSMEX K-4500
Applicant
Sysmex Corp.
Gilmer Rd.
6699 Rfd
Long Grove,  IL  60047
Applicant Contact JEME WALLACE
Correspondent
Sysmex Corp.
Gilmer Rd.
6699 Rfd
Long Grove,  IL  60047
Correspondent Contact JEME WALLACE
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received08/09/1994
Decision Date 02/03/1995
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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