510(k) K861653— GLUCOSE HK PROCEDURE

Substantially Equivalent

Data Medical Associates, Inc.

Clearance details

Applicant: Data Medical Associates, Inc.
Product code: Code CGA
Advisory panel: Clinical Chemistry
Date received: 1986-04-30
Decision date: 1986-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TX, US

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.