CD3 FITC/CD4 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION

Counter, Differential Cell

CALTAG LABORATORIES, INC.

The following data is part of a premarket notification filed by Caltag Laboratories, Inc. with the FDA for Cd3 Fitc/cd4 R-pe/cd45 Tri-color Monoclonal Antibody Combination.

Pre-market Notification Details

Device IDK950919
510k NumberK950919
Device Name:CD3 FITC/CD4 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION
ClassificationCounter, Differential Cell
Applicant CALTAG LABORATORIES, INC. 436 ROZZI PLACE South San Francisco,  CA  94080
ContactTony Lam
CorrespondentTony Lam
CALTAG LABORATORIES, INC. 436 ROZZI PLACE South San Francisco,  CA  94080
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-01
Decision Date1995-12-20

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