The following data is part of a premarket notification filed by Nuclear Diagnostics, Inc. with the FDA for Enzlipase, Enzymatic Lipase Kit.
| Device ID | K862312 |
| 510k Number | K862312 |
| Device Name: | ENZLIPASE, ENZYMATIC LIPASE KIT |
| Classification | Lipase-esterase, Enzymatic, Photometric, Lipase |
| Applicant | NUCLEAR DIAGNOSTICS, INC. 3322 COMMERCIAL AVE. Northbrook, IL 60062 |
| Contact | Glovsky, Ph.d. |
| Correspondent | Glovsky, Ph.d. 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 | 1986-06-18 |
| Decision Date | 1986-09-26 |