CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC

Counter, Differential Cell

COULTER IMMUNOLOGY

The following data is part of a premarket notification filed by Coulter Immunology with the FDA for Cyto-stat(r)/coulter Clone(r) T11-rd1/b4-fitc.

Pre-market Notification Details

Device IDK910473
510k NumberK910473
Device Name:CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC
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 Received1991-02-04
Decision Date1991-10-31

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590541392 K910473 000

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