CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST— 510(k) K882199

Substantially Equivalent

Auspharm Intl. , Ltd.

FDA 510(k) clearance K882199 for CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST, Substantially Equivalent on 1988-10-06. Applicant: Auspharm Intl. , Ltd..

Clearance details

Applicant: Auspharm Intl. , Ltd.
Product code: Code LYR
Advisory panel: Microbiology
Date received: 1988-05-25
Decision date: 1988-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Merrick, NY, 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.