DS30 HCY BLOOD COLLECTION TUBES— 510(k) K012152

Substantially Equivalent

Drew Scientific , Ltd.

FDA 510(k) clearance K012152 for DS30 HCY BLOOD COLLECTION TUBES, Substantially Equivalent on 2001-09-18. Applicant: Drew Scientific , Ltd..

Clearance details

Applicant: Drew Scientific , Ltd.
Product code: Code GIM
Advisory panel: Clinical Chemistry
Date received: 2001-07-11
Decision date: 2001-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barrow In Furness, GB

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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.