WAKO(TM) AUTOKIT GAMMA-GT
Device Facts
| Record ID | K895984 |
|---|---|
| Device Name | WAKO(TM) AUTOKIT GAMMA-GT |
| Applicant | Wako Chemicals USA, Inc. |
| Product Code | JPZ · Clinical Chemistry |
| Decision Date | Nov 8, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1360 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A gamma-glutamyl transpeptidase and isoenzymes test system is a device intended to measure the activity of the enzyme gamma-glutamyl transpeptidase (GGTP) in plasma and serum. Gamma-glutamyl transpeptidase and isoenzymes measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.
