DeviceClearance

Product code KZI— Microbiology

CHOCOLATE AGAR

Classification name
Culture Media, Enriched
Device class
Class 1
Regulation
21 CFR 866.2330
Advisory panel
Microbiology
Total cleared
51
First cleared
Most recent

Market context for product code KZI

FDA has cleared 51 devices under product code KZI between 1982 and 1988, filed by 20 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 KZI

Adverse events under product code KZI

product code KZI
Malfunction
2,834
Total
2,834

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code KZI

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