DeviceClearance

Product code KTN— Immunology

ACCUTEX IM LATEX TEST

Classification name
System, Test, Infectious Mononucleosis
Device class
Class 2
Regulation
21 CFR 866.5640
Advisory panel
Immunology
Total cleared
59
First cleared
Most recent

Market context for product code KTN

FDA has cleared 59 devices under product code KTN between 1976 and 2018, filed by 45 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

last 15 years

Top applicants under product code KTN

Recent clearances under product code KTN

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