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510(k) K210933

YSI 2900C Biochemistry Analyzer by Ysi, Inc. — Product Code CGA

K210933 is an FDA 510(k) premarket notification submitted by Ysi, Inc. for the device "YSI 2900C Biochemistry Analyzer". The FDA issued a decision of Substantially Equivalent on September 30, 2024. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2024
Date Received
March 29, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose Oxidase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

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FDA data resources