K850582 is an FDA 510(k) clearance for the SPQ TEST SYSTEM FOR IMMUNOGLOBULIN A. This device is classified as a Iga, Antigen, Antiserum, Control (Class II - Special Controls, product code CZP).
Submitted by Applications Lab (Scarborough, US). The FDA issued a Cleared decision on March 1, 1985, 16 days after receiving the submission on February 13, 1985.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K850582 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 1985 |
| Decision Date | March 01, 1985 |
| Days to Decision | 16 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 |