DeviceClearance

Product code GSA— Microbiology

MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM

Classification name
Antisera, All Mycoplasma Spp.
Device class
Class 1
Regulation
21 CFR 866.3375
Advisory panel
Microbiology
Total cleared
6
First cleared
Most recent

Market context for product code GSA

FDA has cleared 6 devices under product code GSA between 1986 and 1995, filed by 5 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 GSA

Recent clearances under product code GSA

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