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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 K925255
Device Name TRAX(TM) CD4 TEST KIT
Applicant
T Cell Diagnostics, Inc.
6 Gill St.
Woburn,  MA  01801
Applicant Contact DUFF BRACE
Correspondent
T Cell Diagnostics, Inc.
6 Gill St.
Woburn,  MA  01801
Correspondent Contact DUFF BRACE
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received10/19/1992
Decision Date 05/15/1995
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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