Cleared Traditional

YSI 2900C Biochemistry Analyzer

K210933 · Ysi, Inc. · Chemistry

Sep 2024

Decision

1281d

Days

Class 2

Risk

About This 510(k) Submission

K210933 is an FDA 510(k) clearance for the YSI 2900C Biochemistry Analyzer, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Ysi, Inc. (Yellow Springs, US). The FDA issued a Cleared decision on September 30, 2024, 1281 days after receiving the submission on March 29, 2021. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number	K210933 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 29, 2021
Decision Date	September 30, 2024
Days to Decision	1281 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF