DeviceClearance

K052716

Substantially Equivalent

RAPIRUN H. PYLORI ANTIBODY DETECTION KIT

Applicant
Otsuka Pharmaceutical Co., Ltd.
Product code
LYR
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
North Attleboro, MA, 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.