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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 K911793
Device Name COULTERCLONE
Applicant
Coulter Immunology
440 Coulter Way
West 20th St.
Hialeah,  FL  33010
Applicant Contact MARION S.GAIDE,PH.D.
Correspondent
Coulter Immunology
440 Coulter Way
West 20th St.
Hialeah,  FL  33010
Correspondent Contact MARION S.GAIDE,PH.D.
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received04/22/1991
Decision Date 07/09/1991
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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