COULTER JT3

Counter, Differential Cell

COULTER CORP.

The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Coulter Jt3.

Pre-market Notification Details

Device IDK896873
510k NumberK896873
Device Name:COULTER JT3
ClassificationCounter, Differential Cell
Applicant COULTER CORP. 745 WEST 83RD ST. Hialeah,  FL  33014
ContactA Richardson-jones
CorrespondentA Richardson-jones
COULTER CORP. 745 WEST 83RD ST. Hialeah,  FL  33014
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-12-08
Decision Date1990-03-30

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