K905656

Substantially Equivalent

FLAGEN TRIIODOTHYRONINE (T3) ASSAY

Applicant
Cyberfluor, Inc.
Product code
CDP
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ontario M5t 1x4, CA
Download summary PDF View 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.