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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixture, Hematology Quality Control
510(k) Number K955016
Device Name 4C PLUS COULTER CELL CONTROL
Applicant
Coulter Corp.
11800 SW 147th Ave.
Miami,  FL  33196
Applicant Contact BENITA BOURQUE
Correspondent
Coulter Corp.
11800 SW 147th Ave.
Miami,  FL  33196
Correspondent Contact BENITA BOURQUE
Regulation Number864.8625
Classification Product Code
JPK  
Date Received11/02/1995
Decision Date 01/30/1996
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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