The following data is part of a premarket notification filed by Electro-nucleonics, Inc. with the FDA for Deltatest (r) Lipase Ii.
| Device ID | K893718 |
| 510k Number | K893718 |
| Device Name: | DELTATEST (R) LIPASE II |
| Classification | Olive Oil Emulsion (turbidimetric), Lipase |
| Applicant | ELECTRO-NUCLEONICS, INC. 8310 GUILFORD RD. Columbia, MD 21046 |
| Contact | Karen H Darcy |
| Correspondent | Karen H Darcy ELECTRO-NUCLEONICS, INC. 8310 GUILFORD RD. Columbia, MD 21046 |
| Product Code | CET |
| CFR Regulation Number | 862.1465 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-17 |
| Decision Date | 1989-09-28 |