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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diluent, Blood Cell
510(k) Number K850239
Device Name SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT-
Applicant
Toa Medical Electronics USA, Inc.
1515 E Del Amo Blvd.
Carson,  CA  90746
Applicant Contact MICHAEL L KOHUT
Correspondent
Toa Medical Electronics USA, Inc.
1515 E Del Amo Blvd.
Carson,  CA  90746
Correspondent Contact MICHAEL L KOHUT
Regulation Number864.8200
Classification Product Code
GIF  
Date Received01/22/1985
Decision Date 04/01/1985
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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