The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Gamma-gt.
| Device ID | K923509 |
| 510k Number | K923509 |
| Device Name: | GAMMA-GT |
| Classification | Colorimetric Method, Gamma-glutamyl Transpeptidase |
| Applicant | RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD CRUMLIN, BT29 4QY CO. Antrim, N. Ireland, IR |
| Contact | John Lamont |
| Correspondent | John Lamont RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD CRUMLIN, BT29 4QY CO. Antrim, N. Ireland, IR |
| Product Code | JPZ |
| CFR Regulation Number | 862.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-15 |
| Decision Date | 1992-12-03 |