BLOOD GAS ANALYSIS, STANDARDS CONTROLS— 510(k) K813517

Name: FDA 510(k) clearance K813517
Creator: U.S. Food and Drug Administration
Published: 1981-12-31

Substantially Equivalent

United Diagnostics, Inc.

FDA 510(k) clearance K813517 for BLOOD GAS ANALYSIS, STANDARDS CONTROLS, Substantially Equivalent on 1981-12-31. Applicant: United Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: United Diagnostics, Inc.
Product code: Code CHL
Device class: Class 2
Regulation: 21 CFR 862.1120
Advisory panel: Clinical Chemistry
Date received: 1981-12-16
Decision date: 1981-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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 United Diagnostics, Inc.

view all

K884977 — GAS TRAK PLUS1989-01-27
K862278 — GAS-TRAK1986-08-04
K843986 — STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 31984-11-27
K844018 — GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 31984-11-27
K831389 — STAT-TRAK LIQUID ELECTROLYTE CONTROL1983-08-10

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.