K193115 is an FDA 510(k) clearance for the EUROIMMUN Anti-BP230-CF ELISA (IgG). This device is classified as a Autoantibodies, Skin (bullous Pemphigoid 180 And Bullous Pemphigoid 230 (Class II - Special Controls, product code OEG).
Submitted by Euroimmun Us, Inc. (Mountain Lakes, US). The FDA issued a Cleared decision on September 17, 2020, 310 days after receiving the submission on November 12, 2019.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660. The Device Is Intended As An Aid In The Diagnosis Of Bullous Pemphigoid..
| 510(k) Number | K193115 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 2019 |
| Decision Date | September 17, 2020 |
| Days to Decision | 310 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | OEG - Autoantibodies, Skin (bullous Pemphigoid 180 And Bullous Pemphigoid 230 |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |
| Definition | The Device Is Intended As An Aid In The Diagnosis Of Bullous Pemphigoid. |