K894914

Substantially Equivalent

MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK

Applicant: I-Stat Corp.
Product code: JGS
Advisory panel: Clinical Chemistry
Date received: 1989-08-02
Decision date: 1989-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, 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.