FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇳 China
iClean Viral Transport System (VTM-RT kit)
K Number: K212856
·
Decision Aug 18, 2022
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
110
Applicant Total
1
Review Days
344
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Basic Information
- Device Name
- iClean Viral Transport System (VTM-RT kit)
- K Number
- K212856
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2390
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Huachenyang (Shenzhen) Technology Co. , Ltd.
- Date Received
- September 8, 2021
- Decision Date
- August 18, 2022
- Product Code
- JSM
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- Y
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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