T3 RADIOIMMUNOASSAY KIT— 510(k) K802470

Substantially Equivalent

American Diagnostic Corp.

FDA 510(k) clearance K802470 for T3 RADIOIMMUNOASSAY KIT, Substantially Equivalent on 1980-11-12. Applicant: American Diagnostic Corp..

Clearance details

Applicant
American Diagnostic Corp.
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.