Product code OSK

Device name: Anti-Glutamate Receptor (Type Nmda) Ifa
Medical specialty: Immunology
Device class: 2
Regulation number: 866.5660
Review panel: IM
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Eligible
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.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K100017	EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM	Euroimmun Us, Inc.	2010-09-13

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
04049016092599	Anti-Glutamate receptor (type NMDA) IFA	EUROIMMUN Medizinische Labordiagnostika AG	2025-12-19
04049016092605	Anti-Glutamate receptor (type NMDA) IFA	EUROIMMUN Medizinische Labordiagnostika AG	2025-12-19
04049016092537	Anti-Glutamate receptor (type NMDA) IFA	EUROIMMUN Medizinische Labordiagnostika AG	2016-10-10
04049016092544	Anti-Glutamate receptor (type NMDA) IFA	EUROIMMUN Medizinische Labordiagnostika AG	2016-10-10
04049016092551	Anti-Glutamate receptor (type NMDA) IFA	EUROIMMUN Medizinische Labordiagnostika AG	2016-10-10
04049016092568	Anti-Glutamate receptor (type NMDA) IFA	EUROIMMUN Medizinische Labordiagnostika AG	2016-10-10
04049016092575	Anti-Glutamate receptor (type NMDA) IFA	EUROIMMUN Medizinische Labordiagnostika AG	2016-10-10

Related 510(k) Records#