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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 K964618
Device Name CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME MSIGGI-FITC/MSIGGI-RD1
Applicant
COULTER CORP.
P.O. BOX 169015
MAIMI,  FL  33116 -9015
Applicant Contact MARION S GAIDE
Correspondent
COULTER CORP.
P.O. BOX 169015
MAIMI,  FL  33116 -9015
Correspondent Contact MARION S GAIDE
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received10/15/1996
Decision Date 12/23/1996
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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