The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Digitoxin.
| Device ID | K012112 |
| 510k Number | K012112 |
| Device Name: | RANDOX DIGITOXIN |
| Classification | Enzyme Immunoassay, Digitoxin |
| Applicant | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, County Antrim, GB Bt29 4qy |
| Contact | Pauline Armstrong |
| Correspondent | Pauline Armstrong RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, County Antrim, GB Bt29 4qy |
| Product Code | LFM |
| CFR Regulation Number | 862.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-06 |
| Decision Date | 2002-01-11 |