The following data is part of a premarket notification filed by Nuclear Diagnostics, Inc. with the FDA for Nuclipase (i125) Pancreatic Lipase.
| Device ID | K823860 |
| 510k Number | K823860 |
| Device Name: | NUCLIPASE (I125) PANCREATIC LIPASE |
| Classification | Olive Oil Emulsion (turbidimetric), Lipase |
| Applicant | NUCLEAR DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CET |
| CFR Regulation Number | 862.1465 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-22 |
| Decision Date | 1983-04-18 |