GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT— 510(k) K871835

Name: FDA 510(k) clearance K871835
Creator: U.S. Food and Drug Administration
Published: 1987-12-22

Substantially Equivalent

Miles Laboratories, Inc.

FDA 510(k) clearance K871835 for GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT, Substantially Equivalent on 1987-12-22. Applicant: Miles Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Miles Laboratories, Inc.
Product code: Code CGA
Device class: Class 2
Regulation: 21 CFR 862.1345
Advisory panel: Clinical Chemistry
Date received: 1987-05-11
Decision date: 1987-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

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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.