K011213

Substantially Equivalent

MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM

Applicant: Beckman Coulter, Inc.
Product code: JGS
Advisory panel: Clinical Chemistry
Date received: 2001-04-20
Decision date: 2001-05-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Brea, CA, US

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.