The following data is part of a premarket notification filed by Environmental Chemical Specialties with the FDA for Gamma-glutamyl Transpeptidase (ggt).
| Device ID | K803089 |
| 510k Number | K803089 |
| Device Name: | GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT) |
| Classification | Colorimetric Method, Gamma-glutamyl Transpeptidase |
| Applicant | ENVIRONMENTAL CHEMICAL SPECIALTIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JPZ |
| CFR Regulation Number | 862.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-08 |
| Decision Date | 1981-01-02 |