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 |