ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer— 510(k) K220977

Substantially Equivalent

Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.

FDA 510(k) clearance K220977 for ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer, Substantially Equivalent on 2023-07-20. Applicant: Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd..

Clearance details

Applicant: Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
Product code: Code JGS
Advisory panel: Clinical Chemistry
Date received: 2022-04-04
Decision date: 2023-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code JGS

product code JGS

Malfunction: 535
Total: 535

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.