The following data is part of a premarket notification filed by Euroimmun Us Inc with the FDA for Euroimmun Anti-desmoglein 1 Elisa (igg), Euroimmun Anti-desmoglein 3 Elisa (igg).
| Device ID | K091969 |
| 510k Number | K091969 |
| Device Name: | EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG) |
| Classification | Autoantibodies, Skin (desmoglein 1 And Desmoglein 3) |
| 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 | NBO |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-01 |
| Decision Date | 2010-09-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049016089193 | K091969 | 000 |
| 04049016089186 | K091969 | 000 |