DeviceClearance

Product code MVJ— Immunology

ATHENA MULTI-LYTE GBM TEST SYSTEM

Classification name
Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
Device class
Class 2
Regulation
21 CFR 866.5660
Advisory panel
Immunology
Total cleared
6
First cleared
Most recent

Market context for product code MVJ

FDA has cleared 6 devices under product code MVJ between 1999 and 2007, filed by 6 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 MVJ

Recent clearances under product code MVJ

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