Atlas FDA

BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK

FDA 510(k) clearance K170974 · decided 2017-07-03

Clearance details

K-number
K170974
Device name
BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK
Applicant
Becton, Dickinson and Company
Decision
Substantially Equivalent
Date received
2017-04-03
Decision date
2017-07-03
Days to decision
91 days
Clearance type
Traditional
Product code
OYE
Device class
2
Regulation number
864.5220
Medical specialty
Hematology
Advisory committee
Hematology
Location
San Jose, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
DxFLEX Flow Cytometer; ClearLLab 10C Panels (K232600)Beckman Coulter, Inc.2023-11-22
BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit (K201814)Becton, Dickinson and Company2020-09-28
Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser (K162897)Beckman Coulter2017-06-23
AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS (K141932)Beckman Coulter, Inc.2015-04-10
BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration) (K141468)Bd Biosciences2015-02-27
NAVIOS FLOW CYTOMETER SYSTEM (K130373)Beckman Coulter, Inc.2013-09-18
TETRACHROME REAGENTS AND TETRACXP SYSTEM (K121445)Beckman Coulter, Inc.2013-07-26

Recalls involving this device

RecordFirmDate
FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric" flow recall (Z-0745-2025)Becton, Dickinson and Company, BD Bio Sciences2024-12-23
Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 0038290662876 recall (Z-0746-2025)Becton, Dickinson and Company, BD Bio Sciences2024-12-23
FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 The K170974 cl recall (Z-0747-2025)Becton, Dickinson and Company, BD Bio Sciences2024-12-23
FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 The K170974 c recall (Z-0748-2025)Becton, Dickinson and Company, BD Bio Sciences2024-12-23
FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181 recall (Z-0749-2025)Becton, Dickinson and Company, BD Bio Sciences2024-12-23
BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit with BD Truco recall (Z-2351-2024)Becton, Dickinson and Company, BD Biosciences2024-07-12
BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSL recall (Z-0792-2019)Becton, Dickinson and Company, BD Biosciences2019-02-01
BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Uni recall (Z-2598-2018)Becton, Dickinson and Company, BD Biosciences2018-07-13

PMA approvals by this applicant

RecordFirmDate
BD Onclarity HPV Assay (P160037/S024)Becton, Dickinson and Company2026-04-02
BD Onclarity HPV Assay (P160037/S025)Becton, Dickinson and Company2026-04-02
BD FOX™ PCR Extraction Tubes; BD Onclarity™ HPV Assay (P160037/S026)Becton, Dickinson and Company2026-02-12
BD ONCLARITY HPV ASSAY (P160037/S022)Becton, Dickinson and Company2025-08-25
BD Onclarity HPV Assay (P160037/S023)Becton, Dickinson and Company2025-07-02
Onclarity HPV Assay (P160037/S021)Becton, Dickinson and Company2025-03-12
BD Onclarity™ HPV Assay (P160037/S020)Becton, Dickinson and Company2024-11-05
BD Onclarity HPV Assay (P160037/S017)Becton, Dickinson and Company2024-05-14