Product code GMA— Microbiology

LA-SPORO ANTIBODY SYSTEM

Classification name
Antisera, Fluorescent, Sporothrix Schenekii
Device class
Class 1
Regulation
21 CFR 866.3680
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

Market context for product code GMA

FDA has cleared 1 device under product code GMA, all in 1980, filed by 1 applicant company. 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.

Top applicants under product code GMA

Recent clearances under product code GMA

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