K083615 is an FDA 510(k) clearance for the EUROIMMUN ANTI BP 180-4X 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. (Morristown, US). The FDA issued a Cleared decision on March 16, 2009, 98 days after receiving the submission on December 8, 2008.
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 | K083615 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 2008 |
| Decision Date | March 16, 2009 |
| Days to Decision | 98 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. |