Class Class II
QIAstat-Dx Meningitis/Encephalitis (ME) Panel (K242256)
Description
QIAstat-Dx Meningitis/Encephalitis (ME) Panel by QIAGEN GmbH, an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242256
Clearance Date2024-10-29
Clearance TypeTraditional
Product CodePLO
Regulation Number866.3970
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242256
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 Meningitis/Encephalitis (ME) Panel (K242256) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K160462 | FilmArray Meningitis/Encephalitis (ME) Panel for use with F... | Biofire Diagnostics, LLC | 2016 |
Trace the full predicate network for K242256
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.