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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixture, Hematology Quality Control
510(k) Number K944751
Device Name COULTER FLOW SET
Applicant
Coulter Corp.
P.O. Box 1690
Hialeah,  FL  33011
Applicant Contact THOMAD J ENGLISH
Correspondent
Coulter Corp.
P.O. Box 1690
Hialeah,  FL  33011
Correspondent Contact THOMAD J ENGLISH
Regulation Number864.8625
Classification Product Code
JPK  
Date Received09/26/1994
Decision Date 12/08/1994
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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