IMMUNOCARDSTAT HPSA— 510(k) K032222

Substantially Equivalent

Meridian Bioscience, Inc.

FDA 510(k) clearance K032222 for IMMUNOCARDSTAT HPSA, Substantially Equivalent on 2003-12-05. Applicant: Meridian Bioscience, Inc..

Clearance details

Applicant: Meridian Bioscience, Inc.
Product code: Code LYR
Advisory panel: Microbiology
Date received: 2003-07-21
Decision date: 2003-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

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Adverse events under product code LYR

product code LYR

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.