The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Ez-bead Digoxin Eia Kit.
| Device ID | K893843 |
| 510k Number | K893843 |
| Device Name: | EZ-BEAD DIGOXIN EIA KIT |
| Classification | Enzyme Immunoassay, Digoxin |
| Applicant | IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston, MA 02134 |
| Contact | Francis Capitanio |
| Correspondent | Francis Capitanio IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston, MA 02134 |
| Product Code | KXT |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-25 |
| Decision Date | 1989-09-28 |