The following data is part of a premarket notification filed by Mach Diag. C/o Wichita State University with the FDA for Uri-chem(r) Gk,2,3,4c,5cn,6c,7c And 8c.
| Device ID | K880584 |
| 510k Number | K880584 |
| Device Name: | URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C |
| Classification | Diazonium Colorimetry, Urobilinogen (urinary, Non-quant.) |
| Applicant | MACH DIAG. C/O WICHITA STATE UNIVERSITY WICHITA, KS 67208 |
| Contact | JAMES A JACKSON |
| Correspondent | JAMES A JACKSON MACH DIAG. C/O WICHITA STATE UNIVERSITY WICHITA, KS 67208 |
| Product Code | CDM |
| CFR Regulation Number | 862.1785 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-10 |
| Decision Date | 1988-05-31 |