The following data is part of a premarket notification filed by Euroimmun Us Inc with the FDA for Euroimmun Anti Bp 180-4x Elisa (igg).
| Device ID | K083615 |
| 510k Number | K083615 |
| Device Name: | EUROIMMUN ANTI BP 180-4X ELISA (IGG) |
| Classification | Autoantibodies, Skin (bullous Pemphigoid 180 And Bullous Pemphigoid 230 |
| 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 | OEG |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-08 |
| Decision Date | 2009-03-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049016026839 | K083615 | 000 |