TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE)

Counter, Differential Cell

BECKMAN COULTER, INC.

The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Tetracxp System (software And System Guide).

Pre-market Notification Details

Device IDK030828
510k NumberK030828
Device Name:TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE)
ClassificationCounter, Differential Cell
Applicant BECKMAN COULTER, INC. 11800 SW 147TH AVE. Miami,  FL  33196 -2500
ContactStan Sugrue
CorrespondentStan Sugrue
BECKMAN COULTER, INC. 11800 SW 147TH AVE. Miami,  FL  33196 -2500
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-14
Decision Date2003-05-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590572839 K030828 000
15099590547240 K030828 000
15099590232948 K030828 000
15099590232931 K030828 000

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