DeviceClearance

Product code OSK— Immunology

EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM

Classification name
Anti-Glutamate Receptor (Type Nmda) Ifa
Device class
Class 2
Regulation
21 CFR 866.5660
Advisory panel
Immunology
Total cleared
1
First cleared
Most recent

FDA classification definition

“Intended for the qualitative determination of autoantibodies against glutamate receptor (type NMDA) in human serum. Used as an aid in the diagnosis of anti-glutamate receptor (type NMDA) autoimmune encephalitis in conjunction with other laboratory and clinical findings.”

— U.S. Food and Drug Administration, device classification record for product code OSK under 21 CFR 866.5660, via openFDA

Market context for product code OSK

FDA has cleared 1 device under product code OSK, all in 2010, filed by 1 applicant company. 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.

Top applicants under product code OSK

Recent clearances under product code OSK

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