DeviceClearance

Product code LIE— Microbiology

DIFCO DIRECTOR INOCULATION SYSTEM

Classification name
Reagent/Device, Inoculum Calibration
Device class
Class 2
Regulation
21 CFR 866.1640
Advisory panel
Microbiology
Total cleared
7
First cleared
Most recent

Market context for product code LIE

FDA has cleared 7 devices under product code LIE between 1982 and 2023, filed by 7 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

Top applicants under product code LIE

Recent clearances under product code LIE

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