DeviceClearance

K882199

Substantially Equivalent

CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST

Applicant
Auspharm Intl. , Ltd.
Product code
LYR
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
North Merrick, NY, 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, through . 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.