K881828 is an FDA 510(k) clearance for the IMMUNOGLOBULIN M TEST SYSTEM. This device is classified as a Radioimmunoassay, Immunoglobulins (g, A, M) (Class II - Special Controls, product code CFQ).
Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on June 6, 1988, 38 days after receiving the submission on April 29, 1988.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K881828 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 1988 |
| Decision Date | June 06, 1988 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | CFQ — Radioimmunoassay, Immunoglobulins (g, A, M) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |