The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Axsym Digoxin Iii.
| Device ID | K061249 |
| 510k Number | K061249 |
| Device Name: | AXSYM DIGOXIN III |
| Classification | Enzyme Immunoassay, Digoxin |
| Applicant | ABBOTT LABORATORIES D 9VA, BLDG. AP6C-2 100 ABBOTT PARK RD Abbott Park, IL 60064 -3500 |
| Contact | Kenton Smith |
| Correspondent | Kenton Smith ABBOTT LABORATORIES D 9VA, BLDG. AP6C-2 100 ABBOTT PARK RD Abbott Park, IL 60064 -3500 |
| Product Code | KXT |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-04 |
| Decision Date | 2006-06-02 |
| Summary: | summary |