The following data is part of a premarket notification filed by Nuclear Diagnostics, Inc. with the FDA for Tipsep Digoxin Ria.
| Device ID | K852291 |
| 510k Number | K852291 |
| Device Name: | TIPSEP DIGOXIN RIA |
| Classification | Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Second Antibody Sep. |
| Applicant | NUCLEAR DIAGNOSTICS, INC. 575 ROBBINS DR. Troy, MI 48083 |
| Contact | Smart, Ph.d |
| Correspondent | Smart, Ph.d NUCLEAR DIAGNOSTICS, INC. 575 ROBBINS DR. Troy, MI 48083 |
| Product Code | DNL |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-29 |
| Decision Date | 1985-06-25 |