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Hardy Diagnostics

hardydiagnostics.com ↗ · West Coast

FDA-cleared device company

Hardy Diagnostics is an employee owned company with over 40 years of experience in the microbiology culture media industry. From company website Source · Oct 12, 2026

Keywords: Diagnostics

Profile checked Oct 10, 2026

5FDA records (2 yrs)

Timeline

  1. FDA FDA 510(k) clearance: HardyDisk AST Tebipenem 10µg (TBP10) — K262113, Aug 20, 2026. Applicant at approval: Hardy Diagnostics. source ↗
  2. FDA FDA 510(k) clearance: HardyDisk AST Gepotidacin 10µg (GEP10) — K260842, May 11, 2026. Applicant at approval: Hardy Diagnostics. source ↗
  3. FDA FDA 510(k) clearance: HardyDisk AST Cefiderocol 30µg (FDC30) — K253105, Nov 20, 2025. Applicant at approval: Hardy Diagnostics. source ↗
  4. FDA FDA 510(k) clearance: HardyDisk AST Gepotidacin 10µg (GEP10) — K250956, Jun 26, 2025. Applicant at approval: Hardy Diagnostics. source ↗
  5. FDA FDA 510(k) clearance: HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) — K250454, May 15, 2025. Applicant at approval: Hardy Diagnostics. source ↗

FDA records (last 2 years)

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LinkedIn page linked from the company's own site: source · seen 2026-10-12

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