DeviceClearance

Product code CDP— Clinical Chemistry

AIA-PACK FT3 ASSAY

Classification name
Radioimmunoassay, Total Triiodothyronine
Device class
Class 2
Regulation
21 CFR 862.1710
Advisory panel
Clinical Chemistry
Total cleared
144
First cleared
Most recent

Market context for product code CDP

FDA has cleared 144 devices under product code CDP between 1976 and 2000, filed by 90 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code CDP

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 →

Recent clearances under product code CDP

1–100 of 144

Data sourced from openFDA. This site is unofficial and independent of the FDA.