HELICOBACTER PYLORI IGG ELISA— 510(k) K041238

Substantially Equivalent

Biohit Plc

FDA 510(k) clearance K041238 for HELICOBACTER PYLORI IGG ELISA, Substantially Equivalent on 2004-12-13. Applicant: Biohit Plc.

Clearance details

Applicant: Biohit Plc
Product code: Code LYR
Advisory panel: Microbiology
Date received: 2004-05-11
Decision date: 2004-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Neptune, NJ, 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.