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

Anti-Glutamate Receptor (Type Nmda) Ifa

21 CFR 866.5660 / Immunology
FDA source (opens on fda.gov)

OSK is the FDA product code for Anti-Glutamate Receptor (Type Nmda) Ifa, a class II device type, regulated under 21 CFR 866.5660. FDA's definition for this code 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 laboratory and clinical findings". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OSK
Device name
Anti-Glutamate Receptor (Type Nmda) Ifa
FDA 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.
Regulation
21 CFR 866.5660
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code OSK

By decision year
1 clearance under product code OSK with a decision year between 2010 and 2010, 2010 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OSK by decision year
YearClearances
20101

Applicants with the most clearances

Product code OSK
Applicants holding the most 510(k) clearances under product code OSK
ApplicantClearances
Euroimmun US Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code