The following data is part of a premarket notification filed by Icl Scientific with the FDA for Enzymune-test Digoxin.
| Device ID | K821000 |
| 510k Number | K821000 |
| Device Name: | ENZYMUNE-TEST DIGOXIN |
| Classification | Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep. |
| Applicant | ICL SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DON |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-08 |
| Decision Date | 1982-04-26 |