DeviceClearance

Product code GON— Microbiology

HERPES SIMPLEX TYPE I

Classification name
Antigen, Cf (Including Cf Control), Rubella
Device class
Class 2
Regulation
21 CFR 866.3510
Advisory panel
Microbiology
Total cleared
5
First cleared
Most recent

Market context for product code GON

FDA has cleared 5 devices under product code GON between 1978 and 1989, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code GON

Recent clearances under product code GON

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