CD3 TRI-COLOR/CD4 R-PE/CD8 FITC 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 Tri-color/cd4 R-pe/cd8 Fitc Monoclonal Antibody Combination.

Pre-market Notification Details

Device IDK951073
510k NumberK951073
Device Name:CD3 TRI-COLOR/CD4 R-PE/CD8 FITC 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 Received1995-03-08
Decision Date1995-12-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10190302005265 K951073 000

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