The following data is part of a premarket notification filed by Ortho Diagnostics, Inc. with the FDA for Digoxin Ria (peg) Kit.
| Device ID | K781335 |
| 510k Number | K781335 |
| Device Name: | DIGOXIN RIA (PEG) KIT |
| Classification | Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Polyethylene Glycol |
| Applicant | ORTHO DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DOG |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-02 |
| Decision Date | 1978-08-31 |