K113863 is an FDA 510(k) clearance for the QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS. This device is classified as a Antibodies, Gliadin (Class II - Special Controls, product code MST).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on September 20, 2012, 265 days after receiving the submission on December 30, 2011.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5750.
| 510(k) Number | K113863 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2011 |
| Decision Date | September 20, 2012 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | MST — Antibodies, Gliadin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5750 |