I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER— 510(k) K001154

Substantially Equivalent

I-Stat Corp.

FDA 510(k) clearance K001154 for I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER, Substantially Equivalent on 2000-04-18. Applicant: I-Stat Corp..

Clearance details

Applicant: I-Stat Corp.
Product code: Code JGS
Advisory panel: Clinical Chemistry
Date received: 2000-04-10
Decision date: 2000-04-18
Decision: Substantially Equivalent
Clearance type: Special
Location: East Windsor, NJ, US

Download summary PDF View on FDA.gov ↗

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.