510(k) K083615
K083615 is an FDA 510(k) premarket notification submitted by Euroimmun Us, Inc. for the device "EUROIMMUN ANTI BP 180-4X ELISA (IGG)". The FDA issued a decision of Substantially Equivalent on March 16, 2009. 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
- March 16, 2009
- Date Received
- December 8, 2008
- 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.