DeviceClearance

K990462

Substantially Equivalent

IS H. PYLORI IGG ELISA TEST SYSTEM

Applicant
Columbia Bioscience, Inc.
Product code
LYR
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Columbia, MD, 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.