510(k) clearance
Sol-Guard™ Safety Pull Button Collection Set; Sol-Guard™ XtraThin Safety Pull-Button Blood Collection Set
- 510(k) number
- K260857
- Applicant
- Sol-Millennium Medical, Inc.
- Decision date
- Oct 21, 2026
- Date received
- Mar 16, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- 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
- Chicago, IL, US