Elecsys FT4 III
K-Number: K181233 · 2018-09-18
ApplicantRoche Diagnostics
Decision Date2018-09-18
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Elecsys FT4 III is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2018-09-18 under approval number K181233. The device is classified under product code CEC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Elecsys FT4 III?
Elecsys FT4 III is a medical device that received FDA 510(k) clearance on 2018-09-18. It is manufactured by Roche Diagnostics. The 510(k) number is K181233.
When was Elecsys FT4 III approved by the FDA?
Elecsys FT4 III received FDA 510(k) clearance on 2018-09-18, under approval number K181233.
What company makes Elecsys FT4 III?
Elecsys FT4 III is manufactured by Roche Diagnostics.
What is the FDA product code for Elecsys FT4 III?
The FDA product code for Elecsys FT4 III is CEC.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.