FDA 510(k)

YSI 2900C Biochemistry Analyzer

K-Number: K210933 · 2024-09-30

Decision Date2024-09-30

Product CodeCGA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

YSI 2900C Biochemistry Analyzer is a medical device manufactured by Ysi, Inc.. It received FDA 510(k) clearance on 2024-09-30 under approval number K210933. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the YSI 2900C Biochemistry Analyzer?

YSI 2900C Biochemistry Analyzer is a medical device that received FDA 510(k) clearance on 2024-09-30. It is manufactured by Ysi, Inc.. The 510(k) number is K210933.

When was YSI 2900C Biochemistry Analyzer approved by the FDA?

YSI 2900C Biochemistry Analyzer received FDA 510(k) clearance on 2024-09-30, under approval number K210933.

What company makes YSI 2900C Biochemistry Analyzer?

YSI 2900C Biochemistry Analyzer is manufactured by Ysi, Inc..

What is the FDA product code for YSI 2900C Biochemistry Analyzer?

The FDA product code for YSI 2900C Biochemistry Analyzer is CGA.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.