Class Class II
QIAstat-Dx GI Panel 2 Mini B&V (K243813)
Description
QIAstat-Dx GI Panel 2 Mini B&V by QIAGEN GmbH, an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243813
Clearance Date2025-01-08
Clearance TypeSpecial
Product CodePCH
Regulation Number866.3990
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243813
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. QIAstat-Dx GI Panel 2 Mini B&V (K243813) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220062 | QIAstat-Dx Gastrointestinal Panel 2 | QIAGEN GmbH | 2024 |
Trace the full predicate network for K243813
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.