# Hardy Diagnostics

- Location (FDA's records): Santa Maria, CA
- FDA decisions: 110 (1993–2026): 110 510(k) clearances
- Product codes: JTN (84), JTO (10), JSO (5), PQZ (3), JSM (3), JTY (3), JXC (1), LKS (1)
- 510(k) review time since 2016: median 57 days, against 56 for FDA's reviews in the same codes and years (8 of 19 faster)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 5 (0 its own)
- Recalls linked to its devices: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Remel Co.: 2 (https://510kreport.com/company/remel)
- Bio-Rad: 2 (https://510kreport.com/company/bio-rad)
- bioMerieux, Inc.: 1 (https://510kreport.com/company/biomerieux)
- Copan Diagnostics, Inc.: 1 (https://510kreport.com/company/copan-diagnostics)

## Firms that cite its devices most
- Becton, Dickinson & CO: 2 (https://510kreport.com/company/becton-dickinson)
- Oxoid Limited (Part of Thermo Fisher Scientific): 1 (https://510kreport.com/company/oxoid-part-of-thermo-fisher-scientific)
- Remel Co.: 1 (https://510kreport.com/company/remel)
- Id Biomedical Corp.: 1 (https://510kreport.com/company/id-biomedical)

## Its most-cited devices
- K193504: HardyDisk AST Cefiderocol 30ug (FDC30) (2020), cited by 1
- K172621: HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30) (2017), cited by 1
- K192326: HardyDisk AST Lefamulin 20µg (LMU20) (2019), cited by 1
- K964560: Bhi W/Vancomycin Agar (1997), cited by 1
- K160512: HardyCHROM ESBL (2016), cited by 1

## Recent decisions
- K262113: HardyDisk AST Tebipenem 10µg (TBP10) (Aug 20, 2026)
- K260842: HardyDisk AST Gepotidacin 10µg (GEP10) (May 11, 2026)
- K253105: HardyDisk AST Cefiderocol 30µg (FDC30) (Nov 20, 2025)
- K250956: HardyDisk AST Gepotidacin 10µg (GEP10) (Jun 26, 2025)
- K250454: HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) (May 15, 2025)
- K233534: Viral Transport Medium (Aug 2, 2024)
- K241060: HardyDisk AST Cefiderocol 30µg (FDC30) (Jul 18, 2024)
- K231568: HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) (Jul 6, 2023)

Source page: https://510kreport.com/company/hardy-diagnostics