Urine/CSF Albumin, Urine/CSF Albumin Calibrator

Albumin, Antigen, Antiserum, Control

Beckman Coulter Ireland Inc.

The following data is part of a premarket notification filed by Beckman Coulter Ireland Inc. with the FDA for Urine/csf Albumin, Urine/csf Albumin Calibrator.

Pre-market Notification Details

Device IDK142346
510k NumberK142346
Device Name:Urine/CSF Albumin, Urine/CSF Albumin Calibrator
ClassificationAlbumin, Antigen, Antiserum, Control
Applicant Beckman Coulter Ireland Inc. Lismeehan, O'Callaghan's Mills Co. Clare,  IE
ContactAnne-marie Shine
CorrespondentAnne-marie Shine
Beckman Coulter Ireland Inc. Lismeehan, O'Callaghan's Mills Co. Clare,  IE
Product CodeDCF  
CFR Regulation Number866.5040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-22
Decision Date2014-10-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590670108 K142346 000
15099590666361 K142346 000
15099590020422 K142346 000

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