K821871 is an FDA 510(k) clearance for the ULTRAZYME PLUS 2GT. This device is classified as a Colorimetric Method, Gamma-glutamyl Transpeptidase (Class I - General Controls, product code JPZ).
Submitted by Harleco Diagnostics (Mchenry, US). The FDA issued a Cleared decision on July 14, 1982, 19 days after receiving the submission on June 25, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1360.
| 510(k) Number | K821871 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 1982 |
| Decision Date | July 14, 1982 |
| Days to Decision | 19 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 |