The following data is part of a premarket notification filed by Nuclear Diagnostics, Inc. with the FDA for Nucli-pap Tm-(i125)-pap Radioimmunoas-.
| Device ID | K802886 |
| 510k Number | K802886 |
| Device Name: | NUCLI-PAP TM-(I125)-PAP RADIOIMMUNOAS- |
| Classification | Acid Phosphatase (prostatic), Tartrate Inhibited |
| Applicant | NUCLEAR DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JFH |
| CFR Regulation Number | 862.1020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-17 |
| Decision Date | 1981-01-28 |