FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Biosci Inactivated Transport Medium, Biosci ITM
K Number: K220059
·
Decision Jan 19, 2023
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
16
Applicant Total
3
Review Days
374
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Basic Information
- Device Name
- Biosci Inactivated Transport Medium, Biosci ITM
- K Number
- K220059
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.2950
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shenzhen Dakewe Bio-Engineering Co., Ltd.
- Date Received
- January 10, 2022
- Decision Date
- January 19, 2023
- Product Code
- QBD
- 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 |
|---|---|---|---|
| QBD | Microbial Nucleic Acid Storage And Stabilization Device | FDA class 2 | Microbiology |
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