K082130 is an FDA 510(k) clearance for the EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG). This device is classified as a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II - Special Controls, product code MOB).
Submitted by Euroimmun Us, Inc. (Morristown, US). The FDA issued a Cleared decision on April 7, 2009, 252 days after receiving the submission on July 29, 2008.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K082130 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 2008 |
| Decision Date | April 07, 2009 |
| Days to Decision | 252 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | MOB - Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |