FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇳 China
BioTeke Sterile Disposable Virus Sampling Kit
K Number: K211707
·
Decision May 4, 2022
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
110
Applicant Total
1
Review Days
335
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BioTeke Sterile Disposable Virus Sampling Kit
- K Number
- K211707
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2390
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bioteke Corporation (Wuxi) Co., Ltd.
- Date Received
- June 3, 2021
- Decision Date
- May 4, 2022
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JSM), ordered by most recent decision date.
Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device
FDA 510(k)
FDA Class 1
·Microbiology
Babio® Virus Transport Kit (Non-inactivating)
FDA 510(k)
FDA Class 1
·Microbiology
AllTest Viral Transport Medium
FDA 510(k)
FDA Class 1
·Microbiology
UriSponge
FDA 510(k)
FDA Class 1
·Microbiology
Ensol EnTM Specimen Collection and Transport System
FDA 510(k)
FDA Class 1
·Microbiology
OmniTrans Transport System
FDA 510(k)
FDA Class 1
·Microbiology