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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Glutamate Receptor (Type Nmda) Ifa
510(k) Number K100017
Device Name EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM
Applicant
Euroimmun Us, Inc.
95 Washington St.
Morristown,  NJ  07960
Applicant Contact KATHRYN KOHL
Correspondent
Euroimmun Us, Inc.
95 Washington St.
Morristown,  NJ  07960
Correspondent Contact KATHRYN KOHL
Regulation Number866.5660
Classification Product Code
OSK  
Date Received01/04/2010
Decision Date 09/13/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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