I-STAT TESTS FOR ACID-BASE PARAMETERS— 510(k) K936081

Substantially Equivalent

I-Stat Corp.

FDA 510(k) clearance K936081 for I-STAT TESTS FOR ACID-BASE PARAMETERS, Substantially Equivalent on 1994-02-24. Applicant: I-Stat Corp..

Clearance details

Applicant: I-Stat Corp.
Product code: Code CHL
Advisory panel: Clinical Chemistry
Date received: 1993-12-21
Decision date: 1994-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario K2l 1t9, Canada, CA

Download summary PDF View on FDA.gov ↗

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.