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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 K922745
Device Name CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD1
Applicant
Coulter Immunology
440 Coulter Way
West 20th St.
Hialeah,  FL  33010
Applicant Contact GAIDE
Correspondent
Coulter Immunology
440 Coulter Way
West 20th St.
Hialeah,  FL  33010
Correspondent Contact GAIDE
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received06/08/1992
Decision Date 02/05/1993
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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