Elecsys FT4 IV
K-Number: K220456 · 2023-04-07
ApplicantRoche Diagnostics
Decision Date2023-04-07
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Elecsys FT4 IV is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2023-04-07 under approval number K220456. 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 IV?
Elecsys FT4 IV is a medical device that received FDA 510(k) clearance on 2023-04-07. It is manufactured by Roche Diagnostics. The 510(k) number is K220456.
When was Elecsys FT4 IV approved by the FDA?
Elecsys FT4 IV received FDA 510(k) clearance on 2023-04-07, under approval number K220456.
What company makes Elecsys FT4 IV?
Elecsys FT4 IV is manufactured by Roche Diagnostics.
What is the FDA product code for Elecsys FT4 IV?
The FDA product code for Elecsys FT4 IV 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.