510(k) K053110— Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge

Substantially Equivalent

I-Stat Corporation

Clearance details

Applicant: I-Stat Corporation
Product code: Code JGS
Advisory panel: Clinical Chemistry
Date received: 2005-11-04
Decision date: 2006-01-13
Decision: Substantially Equivalent
Clearance type: Special
Location: East Windsor, NJ, 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.