CALIBRATING SOLUTION FOR ABL-1 & 2— 510(k) K831021

Name: FDA 510(k) clearance K831021
Creator: U.S. Food and Drug Administration
Published: 1983-06-16

Substantially Equivalent

Fisher Scientific Co., LLC

FDA 510(k) clearance K831021 for CALIBRATING SOLUTION FOR ABL-1 & 2, Substantially Equivalent on 1983-06-16. Applicant: Fisher Scientific Co., LLC. Device class: 2.

Clearance details

Applicant: Fisher Scientific Co., LLC
Product code: Code CHL
Device class: Class 2
Regulation: 21 CFR 862.1120
Advisory panel: Clinical Chemistry
Date received: 1983-03-30
Decision date: 1983-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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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.