K914731 is an FDA 510(k) clearance for the TRACE GAMMA GT-SS REAGENT. This device is classified as a Kinetic Method, Gamma-glutamyl Transpeptidase (Class I - General Controls, product code JQB).
Submitted by Trace Scientific , Ltd. (Clayton, Vic 3168, AU). The FDA issued a Cleared decision on November 19, 1991, 29 days after receiving the submission on October 21, 1991.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1360.
| 510(k) Number | K914731 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 1991 |
| Decision Date | November 19, 1991 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JQB — Kinetic Method, Gamma-glutamyl Transpeptidase |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1360 |