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

Name: FDA 510(k) clearance K936081
Creator: U.S. Food and Drug Administration
Published: 1994-02-24

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.. Device class: 2.

Clearance details

Applicant: I-Stat Corp.
Product code: Product code CHL
Device class: Class 2
Regulation: 21 CFR 862.1120
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 ↗

Recent devices under product code CHL

view all

K252207 — ABL90 FLEX PLUS System, safeCLINITUBES2026-04-10
K244014 — i-STAT CG4+ cartridge with the i-STAT 1 System2025-05-02
K240998 — ABL90 FLEX PLUS System2024-12-13
K230285 — i-STAT CG8+ cartridge with the i-STAT 1 System2023-10-27
K221900 — Stat Profile Prime Plus Analyzer System2023-09-29

More clearances from I-Stat Corp.

view all

K012478 — MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER2001-08-20
K011478 — I-STAT SYSTEM2001-07-02
K001387 — I-STAT PORTABLE CLINICAL ANALYZER, MODEL 3002000-10-05
K001154 — I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER2000-04-18
K992571 — I-STAT SYSTEM2000-02-10

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.