ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM— 510(k) K020792

Name: FDA 510(k) clearance K020792
Creator: U.S. Food and Drug Administration
Published: 2002-07-11

Substantially Equivalent

Bayer Diagnostics Corp.

FDA 510(k) clearance K020792 for ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM, Substantially Equivalent on 2002-07-11. Applicant: Bayer Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Bayer Diagnostics Corp.
Product code: Code LDP
Device class: Class 2
Regulation: 21 CFR 862.3030
Advisory panel: Clinical Toxicology
Date received: 2002-03-11
Decision date: 2002-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LDP

product code LDP

Other: 1
Total: 1

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.