The following data is part of a premarket notification filed by Harleco with the FDA for Ultrazyme Plus Gamma Gt(65055-65056).
| Device ID | K820233 |
| 510k Number | K820233 |
| Device Name: | ULTRAZYME PLUS GAMMA GT(65055-65056) |
| 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 | 1982-01-28 |
| Decision Date | 1982-02-12 |