510(k) K193115
K193115 is an FDA 510(k) premarket notification submitted by Euroimmun Us, Inc. for the device "EUROIMMUN Anti-BP230-CF ELISA (IgG)". The FDA issued a decision of Substantially Equivalent on September 17, 2020. The device falls under product code OEG (Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230), a Class II device regulated under 21 CFR 866.5660. Euroimmun Us, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 2020
- Date Received
- November 12, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230
- Device Class
- Class II
- Regulation Number
- 866.5660
- Review Panel
- IM
- Submission Type
The device is intended as an aid in the diagnosis of bullous pemphigoid.