K946192 is an FDA 510(k) clearance for the HICHEM Y-GT REAGENT KIT. This device is classified as a Kinetic Method, Gamma-glutamyl Transpeptidase (Class I - General Controls, product code JQB).
Submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on May 2, 1995, 133 days after receiving the submission on December 20, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1360.
| 510(k) Number | K946192 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 1994 |
| Decision Date | May 02, 1995 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JQB — Kinetic Method, Gamma-glutamyl Transpeptidase |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1360 |