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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 K950742
Device Name CYTO-STAT/COULTER CLONE CD3-ECD/T4-RD1/T8-FITC MONOCLONAL ANTIBOEY REAGENT
Applicant
Coulter Corp.
11800 SW 147th Ave.
Mail Code 31-B06
Miami,  FL  33196
Applicant Contact BENITA B BOURQUE
Correspondent
Coulter Corp.
11800 SW 147th Ave.
Mail Code 31-B06
Miami,  FL  33196
Correspondent Contact BENITA B BOURQUE
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received02/17/1995
Decision Date 08/25/1995
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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