510(k) K801843— T3(125) RADIOIMMUNOASSAY KIT

Substantially Equivalent

Technia Diagnostics , Ltd.

Clearance details

Applicant
Technia Diagnostics , Ltd.
Product code
Code CDP
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code CDP

product code CDP
Malfunction
647
Total
647

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.