EIA FOR DETECTION OF ANTIBODIES H. PYLORI— 510(k) K905409

Substantially Equivalent

E-Z-Em, Inc.

FDA 510(k) clearance K905409 for EIA FOR DETECTION OF ANTIBODIES H. PYLORI, Substantially Equivalent on 1991-06-10. Applicant: E-Z-Em, Inc..

Clearance details

Applicant: E-Z-Em, Inc.
Product code: Code LYR
Advisory panel: Microbiology
Date received: 1990-12-03
Decision date: 1991-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Caldwell, 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.