Class Class I
MycoMEIA Aspergillus Assay (K243496)
Description
MycoMEIA Aspergillus Assay by Pearl Diagnostics, Inc., an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class I
510(k) NumberK243496
Clearance Date2025-08-01
Clearance TypeTraditional
Product CodeNOM
Regulation Number866.3040
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243496
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. MycoMEIA Aspergillus Assay (K243496) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K093678 | PLATELIA ASPERGILLUS EIA MODEL 62793 | Bio-Rad | 2011 |
Trace the full predicate network for K243496
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.