K983880 is an FDA 510(k) clearance for the TRANSFERRIN SPQ III ANTIBODY REAGENT SET. This device is classified as a Transferrin, Antigen, Antiserum, Control (Class II - Special Controls, product code DDG).
Submitted by DiaSorin, Inc. (Columbia, US). The FDA issued a Cleared decision on December 18, 1998, 46 days after receiving the submission on November 2, 1998.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5880.
| 510(k) Number | K983880 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 1998 |
| Decision Date | December 18, 1998 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DDG — Transferrin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5880 |