DeviceClearance

Product code JJB— Clinical Chemistry

BIOSCAN REAGENT STRIPS

Classification name
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
Device class
Class 1
Regulation
21 CFR 862.1115
Advisory panel
Clinical Chemistry
Total cleared
5
First cleared
Most recent

Market context for product code JJB

FDA has cleared 5 devices under product code JJB between 1984 and 1995, filed by 5 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

Top applicants under product code JJB

Recent clearances under product code JJB

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