K252814

Profoject Low Dead Space Syringe /Profoject Tuberculin Syringe; Profoject Low Dead Space Syringe with Needle /Profoject Tuberculin Syringe with Needle; Profoject Low Dead Space Syringe with Permanent Needle /Profoject Tuberculin Syringe with Permanent Needle; Profoject Low Dead Space Safety Syringe /Profoject Tuberculin Safety Syringe

510(k) number: K252814
Device name: Profoject Low Dead Space Syringe /Profoject Tuberculin Syringe; Profoject Low Dead Space Syringe with Needle /Profoject Tuberculin Syringe with Needle; Profoject Low Dead Space Syringe with Permanent Needle /Profoject Tuberculin Syringe with Permanent Needle; Profoject Low Dead Space Safety Syringe /Profoject Tuberculin Safety Syringe
Applicant: CMT Health PTE., Ltd. SG
Product code: QNQ — Low Dead Space Piston Syringe
Decision date: 2026-02-19
Date received: 2025-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General Hospital

PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain

Also available from FDA: K252814.pdf

Official FDA record: K252814

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.