Biosci™ Inactivated Transport Medium, Biosci™ ITM
FDA 510(k) clearance K220059 · decided 2023-01-19
Clearance details
- K-number
- K220059
- Device name
- Biosci™ Inactivated Transport Medium, Biosci™ ITM
- Applicant
- Shenzhen Dakewe Bio-Engineering Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-01-10
- Decision date
- 2023-01-19
- Days to decision
- 374 days
- Clearance type
- Traditional
- Product code
- QBD
- Device class
- 2
- Regulation number
- 866.2950
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.