MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER— 510(k) K012478

Substantially Equivalent

I-Stat Corp.

FDA 510(k) clearance K012478 for MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER, Substantially Equivalent on 2001-08-20. Applicant: I-Stat Corp..

Clearance details

Applicant: I-Stat Corp.
Product code: 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

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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.