K760416 is an FDA 510(k) clearance for the DATA-TOPE SYSTEM DIGOXIN RIA. This device is classified as a Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Polyethylene Glycol (Class II - Special Controls, product code DOG).
Submitted by Dade, Baxter Travenol Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 23, 1976, 14 days after receiving the submission on August 9, 1976.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K760416 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 1976 |
| Decision Date | August 23, 1976 |
| Days to Decision | 14 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 |