The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Digoxin Immunoassay, Elecsys Precicontrol Cardiac Ii.
| Device ID | K153301 |
| 510k Number | K153301 |
| Device Name: | Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II |
| Classification | Enzyme Immunoassay, Digoxin |
| Applicant | ROCHE DIAGNOSTICS 9115 HAGUE ROAD Indianapolis, IN 46250 |
| Contact | Edie Eads |
| Correspondent | Edie Eads ROCHE DIAGNOSTICS 9115 HAGUE ROAD Indianapolis, IN 46250 |
| Product Code | KXT |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-13 |
| Decision Date | 2016-04-08 |