K854416 is an FDA 510(k) clearance for the TDX TRANSFERRIN DIAGNOSTIC KIT. This device is classified as a Transferrin, Antigen, Antiserum, Control (Class II - Special Controls, product code DDG).
Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on February 21, 1986, 109 days after receiving the submission on November 4, 1985.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5880.
| 510(k) Number | K854416 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 1985 |
| Decision Date | February 21, 1986 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DDG — Transferrin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5880 |