K051646

Substantially Equivalent

ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH

Applicant: Pointe Scientific, Inc.,
Product code: JGS
Advisory panel: Clinical Chemistry
Date received: 2005-06-21
Decision date: 2005-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincoln Park, MI, 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.