K031177 is an FDA 510(k) clearance for the DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M. This device is classified as a System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (Class II - Special Controls, product code MSV).
Submitted by Axis-Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on June 19, 2003, 66 days after receiving the submission on April 14, 2003.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K031177 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 2003 |
| Decision Date | June 19, 2003 |
| Days to Decision | 66 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 |