FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Viral Transport Medium
K Number: K233534
·
Decision Aug 2, 2024
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
110
Applicant Total
109
Review Days
273
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Basic Information
- Device Name
- Viral Transport Medium
- K Number
- K233534
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2390
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hardy Diagnostics
- Date Received
- November 3, 2023
- Decision Date
- August 2, 2024
- Product Code
- JSM
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JSM | Culture Media, Non-Propagating Transport | FDA class 1 | Microbiology |
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Other Clearances by Hardy Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K260842 | HardyDisk AST Gepotidacin 10µg (GEP10) | May 11, 2026 | Substantially Equivalent |
| K253105 | HardyDisk AST Cefiderocol 30µg (FDC30) | Nov 20, 2025 | Substantially Equivalent |
| K250956 | HardyDisk AST Gepotidacin 10µg (GEP10) | Jun 26, 2025 | Substantially Equivalent |
| K250454 | HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) | May 15, 2025 | Substantially Equivalent |
| K241060 | HardyDisk AST Cefiderocol 30µg (FDC30) | Jul 18, 2024 | Substantially Equivalent |
| K231568 | HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) | Jul 6, 2023 | Substantially Equivalent |
| K230827 | HardyDisk AST Rezafungin 5µg (RZF5) | Jun 1, 2023 | Substantially Equivalent |
| K193504 | HardyDisk AST Cefiderocol 30ug (FDC30) | Jan 23, 2020 | Substantially Equivalent |
| K192326 | HardyDisk AST Lefamulin 20µg (LMU20) | Sep 19, 2019 | Substantially Equivalent |
| K191931 | HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25) | Jul 31, 2019 | Substantially Equivalent |