OXOID PYLORI TEST KIT, MODEL DR0130M— 510(k) K012588

Name: FDA 510(k) clearance K012588
Creator: U.S. Food and Drug Administration
Published: 2001-12-10

Substantially Equivalent

Oxoid , Ltd.

FDA 510(k) clearance K012588 for OXOID PYLORI TEST KIT, MODEL DR0130M, Substantially Equivalent on 2001-12-10. Applicant: Oxoid , Ltd.. Device class: 1.

Clearance details

Applicant: Oxoid , Ltd.
Product code: Code LYR
Device class: Class 1
Regulation: 21 CFR 866.3110
Advisory panel: Microbiology
Date received: 2001-08-10
Decision date: 2001-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Basingstoke, GB

Download summary PDF View on FDA.gov ↗

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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.