DeviceClearance

Product code KIS— Hematology

FETAL BOVINE SERUM

Classification name
Sera, Animal And Human
Device class
Class 1
Regulation
21 CFR 864.2800
Advisory panel
Hematology
Total cleared
45
First cleared
Most recent

Market context for product code KIS

FDA has cleared 45 devices under product code KIS between 1978 and 1988, filed by 17 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 KIS

Recent clearances under product code KIS

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