HELICOBACTER PYLORI IGG ELISA TEST SYSTEM— 510(k) K980821

Substantially Equivalent

Zeus Scientific, Inc.

FDA 510(k) clearance K980821 for HELICOBACTER PYLORI IGG ELISA TEST SYSTEM, Substantially Equivalent on 1998-07-30. Applicant: Zeus Scientific, Inc..

Clearance details

Applicant: Zeus Scientific, Inc.
Product code: Code LYR
Advisory panel: Microbiology
Date received: 1998-03-03
Decision date: 1998-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raritan, NJ, US

Download summary PDF View on FDA.gov ↗

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.