The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Kallestad Quanticoat 125 Digoxin.
| Device ID | K811776 |
| 510k Number | K811776 |
| Device Name: | KALLESTAD QUANTICOAT 125 DIGOXIN |
| Classification | Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Coated Tube Sep. |
| Applicant | KALLESTAD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DPO |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-23 |
| Decision Date | 1981-07-10 |