K240273

Access Free T4

510(k) number
K240273
Device name
Access Free T4
Applicant
Beckman Coulter, Inc. MN · US
Product code
CEC — Radioimmunoassay, Free Thyroxine
Decision date
2024-03-06
Date received
2024-01-31
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain

Also available from FDA: K240273.pdf

Official FDA record: K240273
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.