The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Lipase.
| Device ID | K812794 |
| 510k Number | K812794 |
| Device Name: | LIPASE |
| Classification | Olive Oil Emulsion (turbidimetric), Lipase |
| Applicant | POINTE SCIENTIFIC, 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 | 1981-10-06 |
| Decision Date | 1981-10-20 |