The following data is part of a premarket notification filed by Pcl-ria, Inc. with the FDA for Digoxin Standards In Human Serum.
| Device ID | K780889 |
| 510k Number | K780889 |
| Device Name: | DIGOXIN STANDARDS IN HUMAN SERUM |
| Classification | Digoxin Control Serum, Ria |
| Applicant | PCL-RIA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DMP |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-05-31 |
| Decision Date | 1978-08-14 |