K781495 is an FDA 510(k) clearance for the RIANEN ASSAY SYSTEM, 125I KIT. This device is classified as a Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Second Antibody Sep. (Class II - Special Controls, product code DNL).
Submitted by New England Nuclear (Mchenry, US). The FDA issued a Cleared decision on September 14, 1978, 15 days after receiving the submission on August 30, 1978.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K781495 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 1978 |
| Decision Date | September 14, 1978 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| 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 |