BICARBONATE CALIBRATOR

Calibrator, Secondary

BECKMAN COULTER IRELAND INC

The following data is part of a premarket notification filed by Beckman Coulter Ireland Inc with the FDA for Bicarbonate Calibrator.

Pre-market Notification Details

Device IDK141374
510k NumberK141374
Device Name:BICARBONATE CALIBRATOR
ClassificationCalibrator, Secondary
Applicant BECKMAN COULTER IRELAND INC 250 S. KRAEMER BLVD. E1.SE.01 Brea,  CA  92821
ContactDavid G Davis
CorrespondentDavid G Davis
BECKMAN COULTER IRELAND INC 250 S. KRAEMER BLVD. E1.SE.01 Brea,  CA  92821
Product CodeJIT  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-05-27
Decision Date2014-06-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590070441 K141374 000

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