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 |