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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 K971469
Device Name COULTER ACT TRON CELL CONTROL
Applicant
Coulter Corp.
11800 SW 147th Ave.
Miami,  FL  33196
Applicant Contact THOMAS J ENGLISH
Correspondent
Coulter Corp.
11800 SW 147th Ave.
Miami,  FL  33196
Correspondent Contact THOMAS J ENGLISH
Regulation Number864.8625
Classification Product Code
JPK  
Date Received04/22/1997
Decision Date 06/30/1997
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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