K012478

Substantially Equivalent

MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER

Applicant: I-Stat Corp.
Product code: CHL
Advisory panel: Clinical Chemistry
Date received: 2001-08-02
Decision date: 2001-08-20
Decision: Substantially Equivalent
Clearance type: Special
Location: East Windsor, NJ, US

Adverse events under product code CHL

product code CHL

Death: 20
Malfunction: 999
Total: 1,019

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.