K152875 is an FDA 510(k) clearance for the QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls. This device is classified as a System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (Class II - Special Controls, product code MSV).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on December 21, 2015, 82 days after receiving the submission on September 30, 2015.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K152875 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2015 |
| Decision Date | December 21, 2015 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | MSV — System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |