510(k) K100017

Device: EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM
Applicant: EUROIMMUN US INC
510(k) number: K100017
Product code: OSK
Decision: Substantially Equivalent (SESE)
Decision date: 2010-09-13
Date received: 2010-01-04
Regulation: 866.5660
Classification name: Anti-glutamate Receptor (type Nmda) Ifa
Medical specialty: Immunology
Review panel: Immunology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

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

summary

Decision Summary