The following data is part of a premarket notification filed by Euroimmun Us Inc with the FDA for Euroimmun Hippocampus/cerebellum/glutamate Receptor/ifa Biochip Mosaic Test System.
| Device ID | K100017 |
| 510k Number | K100017 |
| Device Name: | EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM |
| Classification | Anti-glutamate Receptor (type Nmda) Ifa |
| Applicant | EUROIMMUN US INC 95 WASHINGTON ST Morristown, NJ 07960 |
| Contact | Kathryn Kohl |
| Correspondent | Kathryn Kohl EUROIMMUN US INC 95 WASHINGTON ST Morristown, NJ 07960 |
| Product Code | OSK |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-04 |
| Decision Date | 2010-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049016092575 | K100017 | 000 |
| 04049016092568 | K100017 | 000 |
| 04049016092551 | K100017 | 000 |
| 04049016092544 | K100017 | 000 |
| 04049016092537 | K100017 | 000 |