Class Class II
LIAISON PLEX Gram-Positive Blood Culture Assay (K243490)
Description
LIAISON PLEX Gram-Positive Blood Culture Assay by Luminex Corporation, an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243490
Clearance Date2025-06-06
Clearance TypeTraditional
Product CodePAM
Regulation Number866.3365
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243490
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. LIAISON PLEX Gram-Positive Blood Culture Assay (K243490) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K122514 | VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST | Nanosphere, Inc. | 2012 |
Trace the full predicate network for K243490
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.