510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K880584Substantially Equivalent

Uri-Chem(r) Gk,2,3,4c,5cn,6c,7c and 8C

Mach Diag. C/O Wichita State University, Wichita KS / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880584 is the FDA 510(k) clearance record for URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C, a class I device, cleared for Mach Diag. C/O Wichita State University on under FDA product code CDM (Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)). FDA records list 2 510(k) clearances for Mach Diag. C/O Wichita State University, from to . As of , FDA records show no recalls naming K880584.

Clearance record

Decision date
Received
(111 days to decision)
Product code
CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
Regulation
21 CFR 862.1785
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Mach Diag. C/O Wichita State University
Third party review
No

Clearances, product code CDM

Trailing 12 months

FDA records hold no clearances under product code CDM in the trailing twelve months.

FDA records show no clearances under product code CDM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CDM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260