The following data is part of a premarket notification filed by Pcl-ria, Inc. with the FDA for Rabbit Antibody To Digoxin.
| Device ID | K780316 |
| 510k Number | K780316 |
| Device Name: | RABBIT ANTIBODY TO DIGOXIN |
| Classification | Antiserum, Digoxin |
| Applicant | PCL-RIA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DKA |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-02-24 |
| Decision Date | 1978-03-17 |