Blood Collection Accessory (BUCA)— 510(k) K181754

Substantially Equivalent

Nsp Tech Pte, Ltd.

FDA 510(k) clearance K181754 for Blood Collection Accessory (BUCA), Substantially Equivalent on 2019-07-30. Applicant: Nsp Tech Pte, Ltd..

Clearance details

Applicant: Nsp Tech Pte, Ltd.
Product code: Code JKA
Advisory panel: Clinical Chemistry
Date received: 2018-07-02
Decision date: 2019-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Singapore, SG

Download summary PDF View on FDA.gov ↗

Adverse events under product code JKA

product code JKA

Injury: 455
Malfunction: 26,686
Other: 4
Total: 27,145

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.