K882450

Substantially Equivalent

GEM-STAT W/COMP. GEM-STATPAK/GEM-CHECK & CRIT CHK.

Applicant: Diamond Sensor Systems
Product code: JJE
Advisory panel: Clinical Chemistry
Date received: 1988-06-14
Decision date: 1988-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Adverse events under product code JJE

product code JJE

Death: 6
Injury: 441
Malfunction: 25,011
Other: 1
Total: 25,459

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.