FDA 510(k)
FDA class 1
Substantially Equivalent
🇧🇷 Brazil
Viral Transport Media (VTM)
K Number: K232454
·
Decision May 3, 2024
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
110
Applicant Total
2
Review Days
263
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Basic Information
- Device Name
- Viral Transport Media (VTM)
- K Number
- K232454
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2390
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alb Luz
- Date Received
- August 14, 2023
- Decision Date
- May 3, 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 Alb Luz
| K Number | Device Name | ||
|---|---|---|---|
| K233324 | Molecular Transport Media - MTM | Jun 17, 2024 | Substantially Equivalent |