510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100017Substantially Equivalent

Euroimmun Hippocampus/cerebellum/glutamate Receptor/ifa Biochip Mosaic Test System

Euroimmun US Inc., Morristown NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100017 is the FDA 510(k) clearance record for EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM, a class II device, cleared for Euroimmun Us, Inc. on under FDA product code OSK (Anti-Glutamate Receptor (Type Nmda) Ifa). FDA's definition for product code OSK reads: "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...". FDA records list 37 510(k) clearances for Euroimmun Us, Inc., from to . As of , FDA records show no recalls naming K100017.

Clearance record

Decision date
Received
(252 days to decision)
Product code
OSK Anti-Glutamate Receptor (Type Nmda) Ifa
Regulation
21 CFR 866.5660
Device class
Class II
Review panel
Immunology
Applicant
Euroimmun Us, Inc. 95 Washington St., Morristown NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OSK

Trailing 12 months

FDA records hold no clearances under product code OSK in the trailing twelve months.

FDA records show no clearances under product code OSK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OSK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260