Class Class I
OmniTrans Transport System (K240235)
Description
OmniTrans Transport System by Shenzhen Dakewe Bio-Engineering Co., Ltd., an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class I
510(k) NumberK240235
Clearance Date2024-08-19
Clearance TypeTraditional
Product CodeJSM
Regulation Number866.2390
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240235
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. OmniTrans Transport System (K240235) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K042970 | COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM | Copan Diagnostics, Inc. | 2004 |
Trace the full predicate network for K240235
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.