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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 K951459
Device Name ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE
Applicant
ORTHO DIAGNOSTIC SYSTEMS, INC.
1001 U.S. HIGHWAY 202
P.O. BOX 350
RARITAN,  NJ  08869 -0606
Applicant Contact JOANNE HARRIS
Correspondent
ORTHO DIAGNOSTIC SYSTEMS, INC.
1001 U.S. HIGHWAY 202
P.O. BOX 350
RARITAN,  NJ  08869 -0606
Correspondent Contact JOANNE HARRIS
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received03/30/1995
Decision Date 07/14/1997
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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