510(k) Report

FDA applicant

Mach Diag. C/O Wichita State University

Wichita, KS2 decisions1988–19880 recalls

FDA records 2 decisions for Mach Diag. C/O Wichita State University (Wichita, KS) in 1988: 2 510(k) clearances. Most are in product codes CGA (Glucose Oxidase, Glucose) and CDM (Diazonium Colorimetry, Urobilinogen (Urinary…). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Mach Diag. C/O Wichita State University’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mach Diag. C/O Wichita State University since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mach Diag. C/O Wichita State University by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • CGAGlucose Oxidase, Glucose1decision
  • CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)1decision

What has FDA decided for it lately?

  • K880584Uri-Chem (R) GK,2,3,4C,5CN,6C,7C and 8CMach Diag. C/O Wichita State University · 1988
  • K880585Dexpad, Blood Glucose StripMach Diag. C/O Wichita State University · 1988

All 2 as Mach Diag. C/O Wichita State University →