K781834 is an FDA 510(k) clearance for the TEST SET, 125 I-DIGOXIN. This device is classified as a Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Second Antibody Sep. (Class II - Special Controls, product code DNL).
Submitted by Wien Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 3, 1979, 65 days after receiving the submission on October 30, 1978.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K781834 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 1978 |
| Decision Date | January 03, 1979 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DNL — Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Second Antibody Sep. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |