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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 K945692
Device Name MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD2, CLONE MT910 FITC-CONJUGATED, (ANTI-CD2,FITC, MT910)
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 Received11/21/1994
Decision Date 01/25/1995
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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