K902861 is an FDA 510(k) clearance for the CIBA CORNING ACS DIGOXIN IMMUNOASSAY. This device is classified as a Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep. (Class II - Special Controls, product code DON).
Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on September 10, 1990, 74 days after receiving the submission on June 28, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K902861 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 1990 |
| Decision Date | September 10, 1990 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | DON — Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |