K120817 is an FDA 510(k) clearance for the QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA. This device is classified as a System, Test, Anticardiolipin Immunological (Class II - Special Controls, product code MID).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on February 26, 2013, 344 days after receiving the submission on March 19, 2012.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K120817 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 2012 |
| Decision Date | February 26, 2013 |
| Days to Decision | 344 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | MID — System, Test, Anticardiolipin Immunological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |