510(k) clearance
BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5)
- 510(k) number
- K260215
- Applicant
- Bd Biosciences
- Decision date
- Oct 20, 2026
- Date received
- Jan 23, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- PWD
- Device type
- Flow Cytometric Test System For Hematopoietic Neoplasms
- Device class
- Class II
- Regulation
- 21 CFR 864.7010
- Advisory committee
- Hematology
- Statement or summary
- Summary
- Third party
- N
- Location
- Milpitas, CA, US