Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer

Radioimmunoassay, Thyroid-stimulating Hormone

Beckman Coulter, Inc.

The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Tsh (3rd Is) Assay, Dxi 9000 Access Immunoassay Analyzer.

Pre-market Notification Details

Device IDK221225
510k NumberK221225
Device Name:Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
ClassificationRadioimmunoassay, Thyroid-stimulating Hormone
Applicant Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska,  MN  55318
ContactKuljeet Kaur
CorrespondentKuljeet Kaur
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska,  MN  55318
Product CodeJLW  
CFR Regulation Number862.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-28
Decision Date2022-11-10

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