K100017 is an FDA 510(k) clearance for the EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM. This device is classified as a Anti-glutamate Receptor (type Nmda) Ifa (Class II - Special Controls, product code OSK).
Submitted by Euroimmun Us, Inc. (Morristown, US). The FDA issued a Cleared decision on September 13, 2010, 252 days after receiving the submission on January 4, 2010.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660. 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..
| 510(k) Number | K100017 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 04, 2010 |
| Decision Date | September 13, 2010 |
| Days to Decision | 252 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | OSK - Anti-glutamate Receptor (type Nmda) Ifa |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |
| 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. |