ADH 200 Analyzer Software— 510(k) K143449

Substantially Equivalent

Adams Meditech, LLC

FDA 510(k) clearance K143449 for ADH 200 Analyzer Software, Substantially Equivalent on 2015-06-26. Applicant: Adams Meditech, LLC.

Clearance details

Applicant: Adams Meditech, LLC
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2014-12-02
Decision date: 2015-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: City Of Industry, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

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.