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510(k) K100017

EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM by Euroimmun Us, Inc. — Product Code OSK

K100017 is an FDA 510(k) premarket notification submitted by Euroimmun Us, Inc. for the device "EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on September 13, 2010. The device falls under product code OSK (Anti-Glutamate Receptor (Type Nmda) Ifa), a Class II device regulated under 21 CFR 866.5660. Euroimmun Us, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2010
Date Received
January 4, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Glutamate Receptor (Type Nmda) Ifa
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

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.

Other clearances by Euroimmun Us, Inc.

  • K193115 — EUROIMMUN Anti-BP230-CF ELISA (IgG) (September 17, 2020)
  • K183313 — EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transg (February 28, 2019)
  • K172582 — EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte (May 24, 2018)
  • K172252 — EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern (April 20, 2018)
  • K172244 — EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern (April 20, 2018)
  • K172722 — Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) (December 10, 2017)
  • K161513 — Anti-Borrelia burgdorferi US Westernblot (IgG) (August 25, 2016)
  • K153308 — EUROIMMUN Anti-West Nile Virus ELISA (IgM) (August 12, 2016)
  • K153303 — EUROIMMUN Anti-West Nile Virus ELISA (IgG) (August 10, 2016)
  • K142038 — EUROIMMUN LYME ELISA(IgG/IgM) (May 4, 2015)

FDA data resources