The following data is part of a premarket notification filed by Euroimmun Us, Inc. with the FDA for Euroimmun Anti-bp230-cf Elisa (igg).
| Device ID | K193115 |
| 510k Number | K193115 |
| Device Name: | EUROIMMUN Anti-BP230-CF ELISA (IgG) |
| Classification | Autoantibodies, Skin (bullous Pemphigoid 180 And Bullous Pemphigoid 230 |
| Applicant | Euroimmun US, Inc. 1 Bloomfield Ave. Mountain Lakes, NJ 07046 |
| Contact | Kruti Shah |
| Correspondent | Kruti Shah Euroimmun US Inc 1 Bloomfield Ave. Mountain Lakes, NJ 07046 |
| Product Code | OEG |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-12 |
| Decision Date | 2020-09-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049016091608 | K193115 | 000 |