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510(k) K221826

Device
BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)
Applicant
Becton, Dickinson and Company
510(k) number
K221826
Product code
JTN
Decision
Substantially Equivalent (SESE)
Decision date
2022-12-21
Date received
2022-06-23
Regulation
866.1620
Classification name
Susceptibility Test Discs, Antimicrobial
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Kamisha Gray
Address
7loveton Cir. Sparks MD US 21152 21152

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JTN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260842HardyDisk AST Gepotidacin 10µg (GEP10)Hardy Diagnostics2026-05-11
K251337Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10Thermo Fisher Scientific (Oxoid Ltd.)2025-12-05
K253105HardyDisk AST Cefiderocol 30µg (FDC30)Hardy Diagnostics2025-11-20
K251879Sulopenem SPM 2 µgLiofilchem2025-08-12
K250956HardyDisk AST Gepotidacin 10µg (GEP10)Hardy Diagnostics2025-06-26
K250885Ceftobiprole BPR 5 µg DiscLiofilchem, Inc.2025-06-23
K250789Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50Thermo Fisher Scientific (Oxoid Ltd.)2025-06-12
K250454HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)Hardy Diagnostics2025-05-15
K241060HardyDisk AST Cefiderocol 30µg (FDC30)Hardy Diagnostics2024-07-18
K231806Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5Oxoid Limited (Part of Thermo Fisher Scientific)2024-03-22
K232276Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20Oxoid Limited (Part of Thermo Fisher Scientific)2023-10-06
K231568HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)Hardy Diagnostics2023-07-06
K230651BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)Becton, Dickinson and Company2023-06-07
K230827HardyDisk AST Rezafungin 5µg (RZF5)Hardy Diagnostics2023-06-01
K203336Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30Oxoid Limited (Part of Thermo Fisher Scientific)2022-09-15