K852291 is an FDA 510(k) clearance for the TIPSEP DIGOXIN RIA. This device is classified as a Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Second Antibody Sep. (Class II - Special Controls, product code DNL).
Submitted by Nuclear Diagnostics, Inc. (Troy, US). The FDA issued a Cleared decision on June 25, 1985, 27 days after receiving the submission on May 29, 1985.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K852291 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 1985 |
| Decision Date | June 25, 1985 |
| Days to Decision | 27 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 |