The following data is part of a premarket notification filed by In Vitro Diagnostics, Inc. with the FDA for Digoxin-eia-xt.
| Device ID | K896863 |
| 510k Number | K896863 |
| Device Name: | DIGOXIN-EIA-XT |
| Classification | Enzyme Immunoassay, Digoxin |
| Applicant | IN VITRO DIAGNOSTICS, INC. 8100 SOUTHPARK WAY BLDG. B STE.1 Littleton, CO 80120 |
| Contact | Musick, Phd |
| Correspondent | Musick, Phd IN VITRO DIAGNOSTICS, INC. 8100 SOUTHPARK WAY BLDG. B STE.1 Littleton, CO 80120 |
| Product Code | KXT |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-06 |
| Decision Date | 1990-02-13 |