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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 K950918
Device Name CD3 FITC/CD4 R-PE MONOCLONAL ANTIBODY COMBINATION
Applicant
Caltag Laboratories, Inc.
436 Rozzi Pl.
South San Francisco,  CA  94080
Applicant Contact TONY LAM
Correspondent
Caltag Laboratories, Inc.
436 Rozzi Pl.
South San Francisco,  CA  94080
Correspondent Contact TONY LAM
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received03/01/1995
Decision Date 12/21/1995
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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