K880584 is an FDA 510(k) clearance for the URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C. This device is classified as a Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.) (Class I - General Controls, product code CDM).
Submitted by Mach Diag. C/O Wichita State University (Wichita, US). The FDA issued a Cleared decision on May 31, 1988, 111 days after receiving the submission on February 10, 1988.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1785.
| 510(k) Number | K880584 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 1988 |
| Decision Date | May 31, 1988 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CDM — Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1785 |