K861394 is an FDA 510(k) clearance for the EMIT DIGOXIN MOBILE PHASE SOLUTION. This device is classified as a Enzyme Immunoassay, Digoxin (Class II - Special Controls, product code KXT).
Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on May 29, 1986, 45 days after receiving the submission on April 14, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K861394 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 1986 |
| Decision Date | May 29, 1986 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | KXT — Enzyme Immunoassay, Digoxin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |