K823567 is an FDA 510(k) clearance for the IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM. This device is classified as a Iga, Antigen, Antiserum, Control (Class II - Special Controls, product code CZP).
Submitted by Syva Co. (Walker, US). The FDA issued a Cleared decision on December 30, 1982, 27 days after receiving the submission on December 3, 1982.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K823567 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 1982 |
| Decision Date | December 30, 1982 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | CZP — Iga, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |