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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 K933878
Device Name ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT
Applicant
Intracel Corp.
359 Allston St.
Cambridge,  MA  02139
Applicant Contact CYNTHIA A SINCLAIR
Correspondent
Intracel Corp.
359 Allston St.
Cambridge,  MA  02139
Correspondent Contact CYNTHIA A SINCLAIR
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received08/09/1993
Decision Date 11/14/1995
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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