K850584 is an FDA 510(k) clearance for the SPQ TEST SYSTEM FOR HAPTOGLOBIN. This device is classified as a Haptoglobin, Antigen, Antiserum, Control (Class II - Special Controls, product code DAD).
Submitted by Applications Lab (Scarborough, US). The FDA issued a Cleared decision on March 5, 1985, 20 days after receiving the submission on February 13, 1985.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5460.
| 510(k) Number | K850584 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 1985 |
| Decision Date | March 05, 1985 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DAD — Haptoglobin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5460 |