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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 K960887
Device Name MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPE
Applicant
Dako Corp.
6392 Via Real
Carpinteria,  CA  93013
Applicant Contact GRETCHEN M MURRAY
Correspondent
Dako Corp.
6392 Via Real
Carpinteria,  CA  93013
Correspondent Contact GRETCHEN M MURRAY
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received03/04/1996
Decision Date 05/17/1996
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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