K970551 is an FDA 510(k) clearance for the QUANTA LITE B2GPI IGG. 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 June 24, 1997, 132 days after receiving the submission on February 12, 1997.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K970551 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 1997 |
| Decision Date | June 24, 1997 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | MSV — System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |