The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Endab Digitoxin Enzyme Immunoassay Kit.
| Device ID | K802461 |
| 510k Number | K802461 |
| Device Name: | ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT |
| Classification | Radioimmunoassay, Digitoxin (125-i) |
| Applicant | IMMUNOTECH CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LCW |
| CFR Regulation Number | 862.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-08 |
| Decision Date | 1980-10-31 |