COULTER CLONE T11 MONOCLONAL ANTIBODY

Counter, Differential Cell

COULTER ELECTRONICS, INC.

The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Coulter Clone T11 Monoclonal Antibody.

Pre-market Notification Details

Device IDK875047
510k NumberK875047
Device Name:COULTER CLONE T11 MONOCLONAL ANTIBODY
ClassificationCounter, Differential Cell
Applicant COULTER ELECTRONICS, INC. 440 WEST 20 ST. Hialeah,  FL  33010
ContactEdward J Cassidy
CorrespondentEdward J Cassidy
COULTER ELECTRONICS, INC. 440 WEST 20 ST. Hialeah,  FL  33010
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-12-08
Decision Date1988-03-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590542542 K875047 000
15099590542351 K875047 000
15099590540692 K875047 000
15099590539627 K875047 000

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