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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 K982167
Device Name CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1
Applicant
Coulter Corp.
11800 SW 147th Ave.
Mail Code 31-B06
Miami,  FL  33196
Applicant Contact MARION S GAIDE
Correspondent
Coulter Corp.
11800 SW 147th Ave.
Mail Code 31-B06
Miami,  FL  33196
Correspondent Contact MARION S GAIDE
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received06/19/1998
Decision Date 11/09/1998
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
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