DeviceClearance

Product code JLW— Clinical Chemistry

THYROID STIMULATING HORMONE

Classification name
Radioimmunoassay, Thyroid-Stimulating Hormone
Device class
Class 2
Regulation
21 CFR 862.1690
Advisory panel
Clinical Chemistry
Total cleared
242
First cleared
Most recent

Market context for product code JLW

FDA has cleared 242 devices under product code JLW between 1976 and 2026, filed by 137 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 JLW

Adverse events under product code JLW

product code JLW
Malfunction
885
Total
885

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 JLW

1–100 of 242

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