510(k) clearance
Profoject™ Safe Push Button Blood Collection Sets
- 510(k) number
- K262242
- Applicant
- CMT Health PTE., Ltd.
- Decision date
- Oct 28, 2026
- Date received
- Jul 1, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- JKA
- Device type
- Tubes, Vials, Systems, Serum Separators, Blood Collection
- Device class
- Class II
- Regulation
- 21 CFR 862.1675
- Advisory committee
- Clinical Chemistry
- Statement or summary
- Summary
- Third party
- N
- Location
- Singapore, SG