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510(k) K240273

Access Free T4 by Beckman Coulter, Inc. — Product Code CEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2024
Date Received
January 31, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Free Thyroxine
Device Class
Class II
Regulation Number
862.1695
Review Panel
CH
Submission Type

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  • K131244 — ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET (January 27, 2014)
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