DeviceClearance

Product code CEW— Clinical Chemistry

ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953

Classification name
Radioimmunoassay, Parathyroid Hormone
Device class
Class 2
Regulation
21 CFR 862.1545
Advisory panel
Clinical Chemistry
Total cleared
86
First cleared
Most recent

Market context for product code CEW

FDA has cleared 86 devices under product code CEW between 1977 and 2024, filed by 38 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 CEW

Adverse events under product code CEW

product code CEW
Malfunction
480
Total
480

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 CEW

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