TransFix/EDTA Vacuum Blood Collection Tubes— 510(k) K162723

Substantially Equivalent

Caltag Medsystems, Ltd.

FDA 510(k) clearance K162723 for TransFix/EDTA Vacuum Blood Collection Tubes, Substantially Equivalent on 2017-06-22. Applicant: Caltag Medsystems, Ltd..

Clearance details

Applicant: Caltag Medsystems, Ltd.
Product code: Code GIM
Advisory panel: Clinical Chemistry
Date received: 2016-09-29
Decision date: 2017-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buckingham, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code GIM

product code GIM

Malfunction: 1,325
Total: 1,325

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.