DeviceClearance

Product code JIL— Clinical Chemistry

UROPAPER EIKEN AG

Classification name
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Device class
Class 2
Regulation
21 CFR 862.1340
Advisory panel
Clinical Chemistry
Total cleared
81
First cleared
Most recent

Market context for product code JIL

FDA has cleared 81 devices under product code JIL between 1977 and 2023, filed by 39 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 JIL

Recent clearances under product code JIL

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