Elecsys Folate III
K-Number: K233060 · 2024-06-17
ApplicantRoche Diagnostics
Decision Date2024-06-17
Product CodeCGN
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Elecsys Folate III is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2024-06-17 under approval number K233060. The device is classified under product code CGN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Elecsys Folate III?
Elecsys Folate III is a medical device that received FDA 510(k) clearance on 2024-06-17. It is manufactured by Roche Diagnostics. The 510(k) number is K233060.
When was Elecsys Folate III approved by the FDA?
Elecsys Folate III received FDA 510(k) clearance on 2024-06-17, under approval number K233060.
What company makes Elecsys Folate III?
Elecsys Folate III is manufactured by Roche Diagnostics.
What is the FDA product code for Elecsys Folate III?
The FDA product code for Elecsys Folate III is CGN.
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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.