DeviceClearance

Product code JTL— Microbiology

COAGULASE PLASMA

Classification name
Plasma, Coagulase, Human, Horse And Rabbit
Device class
Class 1
Regulation
21 CFR 866.2160
Advisory panel
Microbiology
Total cleared
12
First cleared
Most recent

Market context for product code JTL

FDA has cleared 12 devices under product code JTL between 1979 and 1995, filed by 10 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 JTL

Recent clearances under product code JTL

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