DEXPAD, BLOOD GLUCOSE STRIP— 510(k) K880585

Name: FDA 510(k) clearance K880585
Creator: U.S. Food and Drug Administration
Published: 1988-04-18

Substantially Equivalent

Mach Diag. C/O Wichita State University

FDA 510(k) clearance K880585 for DEXPAD, BLOOD GLUCOSE STRIP, Substantially Equivalent on 1988-04-18. Applicant: Mach Diag. C/O Wichita State University. Device class: 2.

Clearance details

Applicant: Mach Diag. C/O Wichita State University
Product code: Code CGA
Device class: Class 2
Regulation: 21 CFR 862.1345
Advisory panel: Clinical Chemistry
Date received: 1988-02-10
Decision date: 1988-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wichita, KS, US

Download summary PDF View on FDA.gov ↗

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K880584 — URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C1988-05-31

Adverse events under product code CGA

product code CGA

Death: 2
Malfunction: 1,816
Total: 1,818

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.