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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 K990172
Device Name TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA
Applicant
Coulter Corp.
11800 SW 147th Ave.
Miami,  FL  33196 -2500
Applicant Contact MARION S GAIDE
Correspondent
Coulter Corp.
11800 SW 147th Ave.
Miami,  FL  33196 -2500
Correspondent Contact MARION S GAIDE
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received01/19/1999
Decision Date 04/13/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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