CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT IWTH ISOTYPIC CONTROL

Counter, Differential Cell

COULTER CORP.

The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Cyto-stat Trichrome Cd45-fitc/cd8-rd1/cd3-pc5 Monoclonal Antibody Reagent Iwth Isotypic Control.

Pre-market Notification Details

Device IDK962305
510k NumberK962305
Device Name:CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT IWTH ISOTYPIC CONTROL
ClassificationCounter, Differential Cell
Applicant COULTER CORP. 11800 S.W. 147TH AVE. Miami,  FL  33196 -2500
ContactMarion S Gaide
CorrespondentMarion S Gaide
COULTER CORP. 11800 S.W. 147TH AVE. Miami,  FL  33196 -2500
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-17
Decision Date1997-01-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590540401 K962305 000

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