K924769 is an FDA 510(k) clearance for the IMMUNOGLOBULINS G, A & M AND LIGHT CHAIN SPECIFIC. This device is classified as a Immunoelectrophoretic, Immunoglobulins, (g, A, M) (Class II - Special Controls, product code CFF).
Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on February 23, 1993, 153 days after receiving the submission on September 23, 1992.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K924769 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 1992 |
| Decision Date | February 23, 1993 |
| Days to Decision | 153 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | CFF — Immunoelectrophoretic, Immunoglobulins, (g, A, M) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |