BLOOD GAS FLUSH SOL. & FLUSH AGENT 1302— 510(k) K842519

Name: FDA 510(k) clearance K842519
Creator: U.S. Food and Drug Administration
Published: 1984-08-17

Substantially Equivalent

Rna Medical Corp.

FDA 510(k) clearance K842519 for BLOOD GAS FLUSH SOL. & FLUSH AGENT 1302, Substantially Equivalent on 1984-08-17. Applicant: Rna Medical Corp.. Device class: 2.

Clearance details

Applicant: Rna Medical Corp.
Product code: Code CHL
Device class: Class 2
Regulation: 21 CFR 862.1120
Advisory panel: Clinical Chemistry
Date received: 1984-07-10
Decision date: 1984-08-17
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.