DeviceClearance

Product code JIR— Clinical Chemistry

BIOTROL URINE PROTEINS REAGENT

Classification name
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Device class
Class 1
Regulation
21 CFR 862.1645
Advisory panel
Clinical Chemistry
Total cleared
38
First cleared
Most recent

Market context for product code JIR

FDA has cleared 38 devices under product code JIR between 1981 and 2023, filed by 28 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

last 15 years

Top applicants under product code JIR

Recent clearances under product code JIR

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