K112545 is an FDA 510(k) clearance for the QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM. This device is classified as a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II - Special Controls, product code MOB).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on July 31, 2012, 334 days after receiving the submission on September 1, 2011.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K112545 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 2011 |
| Decision Date | July 31, 2012 |
| Days to Decision | 334 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 |