K923509 is an FDA 510(k) clearance for the GAMMA-GT. This device is classified as a Colorimetric Method, Gamma-glutamyl Transpeptidase (Class I - General Controls, product code JPZ).
Submitted by Randox Laboratories, Ltd. (Antrim, N. Ireland, IR). The FDA issued a Cleared decision on December 3, 1992, 141 days after receiving the submission on July 15, 1992.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1360.
| 510(k) Number | K923509 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 1992 |
| Decision Date | December 03, 1992 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JPZ — Colorimetric Method, Gamma-glutamyl Transpeptidase |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1360 |