DeviceClearance

Product code DBY— Immunology

BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER

Classification name
Fab, Rhodamine, Antigen, Antiserum, Control
Device class
Class 1
Regulation
21 CFR 866.5520
Advisory panel
Immunology
Total cleared
6
First cleared
Most recent

Market context for product code DBY

FDA has cleared 6 devices under product code DBY between 1977 and 2002, 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 DBY

Recent clearances under product code DBY

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