Chrysalis Intelligence · Product Codes · JTN

JTN · Susceptibility Test Discs, Antimicrobial

Microbiology · 22 clearances · 5 unique sponsors

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Device class
Class II
Regulation 866.1620
Total clearances
22
2020-01-23 → 2026-07-24
Last 12 months
5
Unique sponsors
5
Classification details
Medical specialty
Microbiology
Review panel
MI
Regulation number
866.1620
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Hardy Diagnostics 8 2 2026-05-11
Oxoid Limited (Part of Thermo Fisher Scientific) 6 0 2024-03-22
Thermo Fisher Scientific (Oxoid Ltd.) 3 2 2026-07-24
Liofilchem, Inc. 3 1 2026-07-23
Becton, Dickinson and Company 2 0 2023-06-07
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
87181 CPT — High Antimicrobial susceptibility disc diffusion testing standard microbiology procedure
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-24 K261781 Thermo Fisher Scientific (Oxoid Ltd.) Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60
2026-07-23 K261853 Liofilchem, Inc. Gepotidacin GEP 10 µg
2026-05-11 K260842 Hardy Diagnostics HardyDisk AST Gepotidacin 10µg (GEP10)
2025-12-05 K251337 Thermo Fisher Scientific (Oxoid Ltd.) Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10
2025-11-20 K253105 Hardy Diagnostics HardyDisk AST Cefiderocol 30µg (FDC30)
2025-08-12 K251879 Liofilchem Sulopenem SPM 2 µg
2025-06-26 K250956 Hardy Diagnostics HardyDisk AST Gepotidacin 10µg (GEP10)
2025-06-23 K250885 Liofilchem, Inc. Ceftobiprole BPR 5 µg Disc
2025-06-12 K250789 Thermo Fisher Scientific (Oxoid Ltd.) Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50
2025-05-15 K250454 Hardy Diagnostics HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)
2024-07-18 K241060 Hardy Diagnostics HardyDisk AST Cefiderocol 30µg (FDC30)
2024-03-22 K231806 Oxoid Limited (Part of Thermo Fisher Scientific) Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5
2023-10-06 K232276 Oxoid Limited (Part of Thermo Fisher Scientific) Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20
2023-07-06 K231568 Hardy Diagnostics HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)
2023-06-07 K230651 Becton, Dickinson and Company BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)
2023-06-01 K230827 Hardy Diagnostics HardyDisk AST Rezafungin 5µg (RZF5)
2022-12-21 K221826 Becton, Dickinson and Company BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)
2022-09-15 K203336 Oxoid Limited (Part of Thermo Fisher Scientific) Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30
2021-10-27 K210873 Oxoid Limited (Part of Thermo Fisher Scientific) Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20
2021-07-30 K203700 Oxoid Limited (Part of Thermo Fisher Scientific) Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30
2020-12-04 K193508 Oxoid Limited (Part of Thermo Fisher Scientific) Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20
2020-01-23 K193504 Hardy Diagnostics HardyDisk AST Cefiderocol 30ug (FDC30)
Data source: openFDA · Generated 2026-08-13 09:11 · Last ingest 2026-08-13T13:11:05.724757 · Pipeline: Chrysalis Intelligence