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 the device name listed in this FDA 510(k) record. The listed applicant is Ysi, Inc.. It received FDA 510(k) clearance on 2024-09-30 under 510(k) 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. The listed applicant is Ysi, Inc.. The 510(k) number is K210933.

When did YSI 2900C Biochemistry Analyzer receive FDA 510(k) clearance?

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

Who is the listed applicant for YSI 2900C Biochemistry Analyzer?

The FDA 510(k) record lists Ysi, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: 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.