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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 K963954
Device Name CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY
Applicant
Caltag Laboratories, Inc.
605 Dilworth Rd.
Dowingtown,  PA  19335
Applicant Contact DAVID C BISHOP
Correspondent
Caltag Laboratories, Inc.
605 Dilworth Rd.
Dowingtown,  PA  19335
Correspondent Contact DAVID C BISHOP
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received10/02/1996
Decision Date 11/25/1996
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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