The following data is part of a premarket notification filed by Harleco with the FDA for Ultrazyme-gt, Item #64959 & 65032.
| Device ID | K813041 |
| 510k Number | K813041 |
| Device Name: | ULTRAZYME-GT, ITEM #64959 & 65032 |
| Classification | Kinetic Method, Gamma-glutamyl Transpeptidase |
| Applicant | HARLECO 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JQB |
| CFR Regulation Number | 862.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-28 |
| Decision Date | 1981-11-10 |