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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, White-Cell
510(k) Number K894651
Device Name COULTER POSITIVE CONTROL CELLS
Applicant
Coulter Corp.
600 Coulter Way
Hialeah,  FL  33010
Applicant Contact GREGORY BUTCHKO
Correspondent
Coulter Corp.
600 Coulter Way
Hialeah,  FL  33010
Correspondent Contact GREGORY BUTCHKO
Regulation Number864.8625
Classification Product Code
GGL  
Date Received07/24/1989
Decision Date 09/13/1989
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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