Biosci™ Inactivated Transport Medium, Biosci™ ITM (K220059)
Description
Biosci™ Inactivated Transport Medium, Biosci™ ITM by Shenzhen Dakewe Bio-Engineering Co., Ltd., an FDA 510(k) cleared microbiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K220059
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Biosci™ Inactivated Transport Medium, Biosci™ ITM (K220059) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201849 | eNAT molecular collection and preservation medium | Copan Italia Spa | 2020 |
Trace the full predicate network for K220059
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.