The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Randox Digoxin.
| Device ID | K011302 |
| 510k Number | K011302 |
| Device Name: | RANDOX DIGOXIN |
| Classification | Enzyme Immunoassay, Digoxin |
| Applicant | RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, Co. Antrim, IE Bt29 4qy |
| Contact | Pauline Armstrong |
| Correspondent | Pauline Armstrong RANDOX LABORATORIES, LTD. 55 DIAMOND RD. Crumlin, Co. Antrim, IE Bt29 4qy |
| Product Code | KXT |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-30 |
| Decision Date | 2001-07-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414595863 | K011302 | 000 |
| 00630414470375 | K011302 | 000 |