The following data is part of a premarket notification filed by Lkb Instruments, Inc. with the FDA for Delfia Digoxin.
| Device ID | K861195 |
| 510k Number | K861195 |
| Device Name: | DELFIA DIGOXIN |
| Classification | Enzyme Immunoassay, Digoxin |
| Applicant | LKB INSTRUMENTS, INC. 9319 GAITHER RD. Gaithersburg, MD 20877 |
| Contact | Lkb Instruments |
| Correspondent | Lkb Instruments LKB INSTRUMENTS, INC. 9319 GAITHER RD. Gaithersburg, MD 20877 |
| Product Code | KXT |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-31 |
| Decision Date | 1986-07-11 |