510(k) K240273

Device
Access Free T4
Applicant
Beckman Coulter, Inc.
510(k) number
K240273
Product code
CEC
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-06
Date received
2024-01-31
Regulation
862.1695
Classification name
Radioimmunoassay, Free Thyroxine
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Muhammad Sheikh
Address
1000 Lake Hazeltine Dr. Chaska MN US 55318 55318

FDA Registration Numbers

Source Documents

510(k) summary PDF

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