DeviceClearance

Product code LKI— Microbiology

BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE

Classification name
Antisera, Fluorescent, Chlamydia Spp.
Device class
Class 1
Regulation
21 CFR 866.3120
Advisory panel
Microbiology
Total cleared
6
First cleared
Most recent

Market context for product code LKI

FDA has cleared 6 devices under product code LKI between 1983 and 1992, filed by 6 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 LKI

Recent clearances under product code LKI

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