DIATRON PICTUS 400— 510(k) K101741

Substantially Equivalent

Diatron Group

FDA 510(k) clearance K101741 for DIATRON PICTUS 400, Substantially Equivalent on 2011-01-25. Applicant: Diatron Group.

Clearance details

Applicant: Diatron Group
Product code: Code CGA
Advisory panel: Clinical Chemistry
Date received: 2010-06-22
Decision date: 2011-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westo, FL, US

Download summary PDF View on FDA.gov ↗

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.