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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 K914848
Device Name CD4 MONOCLONAL ANTIBODIES
Applicant
Gen Trak, Inc.
5100 Campus Dr.
Plymouth Meeting,  PA  19462
Applicant Contact DEBORAH L.LINDMOUTH
Correspondent
Gen Trak, Inc.
5100 Campus Dr.
Plymouth Meeting,  PA  19462
Correspondent Contact DEBORAH L.LINDMOUTH
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received10/28/1991
Decision Date 06/19/1992
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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