CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI

Counter, Differential Cell

COULTER IMMUNOLOGY

The following data is part of a premarket notification filed by Coulter Immunology with the FDA for Cyto-stat/coulter Clone T4-rd1/t8-fitc Mono Anti.

Pre-market Notification Details

Device IDK895917
510k NumberK895917
Device Name:CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI
ClassificationCounter, Differential Cell
Applicant COULTER IMMUNOLOGY 440 COULTER WAY WEST 20TH STREET Hialeah,  FL  33010
ContactGregory M Butchko
CorrespondentGregory M Butchko
COULTER IMMUNOLOGY 440 COULTER WAY WEST 20TH STREET Hialeah,  FL  33010
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-10-10
Decision Date1989-12-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590541385 K895917 000
15099590539726 K895917 000

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