ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer— 510(k) K161837

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K161837 for ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer, Substantially Equivalent on 2016-12-16. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code JGS
Advisory panel: Clinical Chemistry
Date received: 2016-07-05
Decision date: 2016-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

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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.