K941878

Substantially Equivalent

OCTEIA INTACT PTH

Applicant
I.D.S.
Product code
CEW
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tyne & Wear, GB
Download summary PDF View on FDA.gov ↗

Adverse events under product code CEW

product code CEW
Malfunction
480
Total
480

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.