K153301 is an FDA 510(k) clearance for the Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II. This device is classified as a Enzyme Immunoassay, Digoxin (Class II - Special Controls, product code KXT).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on April 8, 2016, 147 days after receiving the submission on November 13, 2015.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K153301 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2015 |
| Decision Date | April 08, 2016 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | KXT — Enzyme Immunoassay, Digoxin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |