Product code KZK— Microbiology

BIOMIC MICROBIOLOGY DATA MANAGEMENT SYSTEM

Classification name
Reader, Zone, Automated
Device class
Class 1
Regulation
21 CFR 866.2850
Advisory panel
Microbiology
Total cleared
3
First cleared
Most recent

Market context for product code KZK

FDA has cleared 3 devices under product code KZK between 1994 and 1999, filed by 2 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 KZK

Recent clearances under product code KZK

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