510(k) clearances

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)

Bd Biosciences · Hematology

K260215Substantially EquivalentTraditionalOYE
Open FDA's page for this record
Third party flag
N
City
Milpitas
Advisory committee description
Hematology
Address 1
155 N. Mccarthy Blvd.
Statement or summary
Summary
Product code
OYE
Zip code
95035
Applicant
Bd Biosciences
Decision date
2026-10-20
Decision code
SESE
Country code
US
Device name
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)
Advisory committee
HE
Contact
Jeff Yarch
K number
K260215
State
CA
Date received
2026-01-23
Review advisory committee
IM
Postal code
95035
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Flow Cytometric Reagents And Accessories.
Medical specialty description
Hematology
Regulation number
864.5220
Device class
2
Registration number
1064130, 8043379, 1017835, 1061932, 8023018, 3027394506, 3003244710, 3016954941, 3008494306, 3003589956, 3008352382
FEI number
3002684533, 3002807272, 1017835, 3000203293, 3027394506, 3003589956, 3003244710, 3016954941, 3008494306, 3003413192, 3008352382
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.