The following data is part of a premarket notification filed by Nuclear Diagnostics, Inc. with the FDA for Elipase Human Pancreatic Lipase Enzymeimmunoassay.
| Device ID | K923917 |
| 510k Number | K923917 |
| Device Name: | ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY |
| Classification | Lipase-esterase, Enzymatic, Photometric, Lipase |
| Applicant | NUCLEAR DIAGNOSTICS, INC. 3322 COMMERCIAL AVE. Northbrook, IL 60062 |
| Contact | Joel Glovsky |
| Correspondent | Joel Glovsky NUCLEAR DIAGNOSTICS, INC. 3322 COMMERCIAL AVE. Northbrook, IL 60062 |
| Product Code | CHI |
| CFR Regulation Number | 862.1465 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-05 |
| Decision Date | 1994-02-25 |