COULTER LIN-X LINEARITY CONTROL

Mixture, Hematology Quality Control

BECKMAN COULTER, INC.

The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Coulter Lin-x Linearity Control.

Pre-market Notification Details

Device IDK081641
510k NumberK081641
Device Name:COULTER LIN-X LINEARITY CONTROL
ClassificationMixture, Hematology Quality Control
Applicant BECKMAN COULTER, INC. 11800 SW 147TH AVE. M/S 31-B06 Miami,  FL  33196 -2500
ContactNancy Nadler
CorrespondentNancy Nadler
BECKMAN COULTER, INC. 11800 SW 147TH AVE. M/S 31-B06 Miami,  FL  33196 -2500
Product CodeJPK  
CFR Regulation Number864.8625 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-06-11
Decision Date2009-01-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590233792 K081641 000
15099590206802 K081641 000

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