YSI 2900C Biochemistry Analyzer— 510(k) K210933

Substantially Equivalent

Ysi, Inc.

FDA 510(k) clearance K210933 for YSI 2900C Biochemistry Analyzer, Substantially Equivalent on 2024-09-30. Applicant: Ysi, Inc..

Clearance details

Applicant: Ysi, Inc.
Product code: Code CGA
Advisory panel: Clinical Chemistry
Date received: 2021-03-29
Decision date: 2024-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yellow Springs, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CGA

product code CGA

Death: 2
Malfunction: 1,816
Total: 1,818

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.