K143483 is an FDA 510(k) clearance for the MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING. This device is classified as a Immunoelectrophoretic, Immunoglobulins, (g, A, M) (Class II - Special Controls, product code CFF).
Submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on January 8, 2015, 31 days after receiving the submission on December 8, 2014.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K143483 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 2014 |
| Decision Date | January 08, 2015 |
| Days to Decision | 31 days |
| Submission Type | Special |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | CFF — Immunoelectrophoretic, Immunoglobulins, (g, A, M) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |