K851329

Substantially Equivalent

MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA

Applicant
Corning Medical & Scientific
Product code
JLW
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Medfield, MA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code JLW

product code JLW
Malfunction
885
Total
885

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.