K810477 is an FDA 510(k) clearance for the DCA DIGOX-SYN RIA TEST. This device is classified as a Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Polyethylene Glycol (Class II - Special Controls, product code DOG).
Submitted by Diagnostic Corp. of America (Mchenry, US). The FDA issued a Cleared decision on March 11, 1981, 16 days after receiving the submission on February 23, 1981.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K810477 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 1981 |
| Decision Date | March 11, 1981 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DOG — Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Polyethylene Glycol |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |