DeviceClearance

K051810

Substantially Equivalent

WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014

Applicant
Scantibodies Laboratory, Inc.
Product code
CEW
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Santee, CA, US
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.