The following data is part of a premarket notification filed by Harleco with the FDA for Ultra Chem E-trig #65024.
| Device ID | K812589 |
| 510k Number | K812589 |
| Device Name: | ULTRA CHEM E-TRIG #65024 |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Applicant | HARLECO 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CDT |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-11 |
| Decision Date | 1981-09-24 |