K803089 is an FDA 510(k) clearance for the GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT). This device is classified as a Colorimetric Method, Gamma-glutamyl Transpeptidase (Class I - General Controls, product code JPZ).
Submitted by Environmental Chemical Specialties (Mchenry, US). The FDA issued a Cleared decision on January 2, 1981, 25 days after receiving the submission on December 8, 1980.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1360.
| 510(k) Number | K803089 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 1980 |
| Decision Date | January 02, 1981 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JPZ — Colorimetric Method, Gamma-glutamyl Transpeptidase |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1360 |