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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 K984216
Device Name IMMUNO-TROL CONTROL CELLS
Applicant
Coulter Corp.
11800 SW 147th Ave.
Miami,  FL  33196
Applicant Contact MARION S GAIDE
Correspondent
Coulter Corp.
11800 SW 147th Ave.
Miami,  FL  33196
Correspondent Contact MARION S GAIDE
Regulation Number864.8625
Classification Product Code
JPK  
Date Received11/24/1998
Decision Date 03/16/1999
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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