The following data is part of a premarket notification filed by Wien Laboratories, Inc. with the FDA for 125i Digoxin Test Set.
| Device ID | K772306 |
| 510k Number | K772306 |
| Device Name: | 125I DIGOXIN TEST SET |
| Classification | Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Charcoal Sep. |
| Applicant | WIEN LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DPB |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-12-15 |
| Decision Date | 1977-12-22 |