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

Substantially Equivalent

Bayer Diagnostics Corp.

Clearance details

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

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.