DeviceClearance

Product code CEC— Clinical Chemistry

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Classification name
Radioimmunoassay, Free Thyroxine
Device class
Class 2
Regulation
21 CFR 862.1695
Advisory panel
Clinical Chemistry
Total cleared
92
First cleared
Most recent

Market context for product code CEC

FDA has cleared 92 devices under product code CEC between 1977 and 2024, filed by 57 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 CEC

Adverse events under product code CEC

product code CEC
Malfunction
899
Total
899

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 CEC

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