Biosci Inactivated Transport Medium, Biosci ITM
K-Number: K220059 · 2023-01-19
Decision Date2023-01-19
Product CodeQBD
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Biosci Inactivated Transport Medium, Biosci ITM is a medical device manufactured by Shenzhen Dakewe Bio-Engineering Co., Ltd.. It received FDA 510(k) clearance on 2023-01-19 under approval number K220059. The device is classified under product code QBD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Biosci Inactivated Transport Medium, Biosci ITM?
Biosci Inactivated Transport Medium, Biosci ITM is a medical device that received FDA 510(k) clearance on 2023-01-19. It is manufactured by Shenzhen Dakewe Bio-Engineering Co., Ltd.. The 510(k) number is K220059.
When was Biosci Inactivated Transport Medium, Biosci ITM approved by the FDA?
Biosci Inactivated Transport Medium, Biosci ITM received FDA 510(k) clearance on 2023-01-19, under approval number K220059.
What company makes Biosci Inactivated Transport Medium, Biosci ITM?
Biosci Inactivated Transport Medium, Biosci ITM is manufactured by Shenzhen Dakewe Bio-Engineering Co., Ltd..
What is the FDA product code for Biosci Inactivated Transport Medium, Biosci ITM?
The FDA product code for Biosci Inactivated Transport Medium, Biosci ITM is QBD.
Other Devices by Shenzhen Dakewe Bio-Engineering Co., Ltd.
Related Devices (Code: QBD)
DEN170029PrimeStore MTMLonghorn Vaccines and Diagnostics, LLC
K202641DNA/RNA Shield Collection TubeZymo Research
K201849eNAT molecular collection and preservation mediumCopan Italia Spa
K210440Disposable Sampler Inactivated Transport Media, Nest ITMWuxi Nest Biotechnology Co., Ltd.
K211675Dasky Disposable Sampling Tube (Model name: VSM02)Ningbo Dasky Life Science Co., Ltd.
K212113MagXtract Collection TubeMagbio Genomics, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.