Class Class II
IVD CAPSULE PSP; abioSCOPE (K240041)
Description
IVD CAPSULE PSP; abioSCOPE by Abionic SA, an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240041
Clearance Date2024-09-25
Clearance TypeTraditional
Product CodeSCX
Regulation Number866.3215
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240041
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. IVD CAPSULE PSP; abioSCOPE (K240041) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K070310 | B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM | Brahms Aktiengesellschaft | 2008 |
Trace the full predicate network for K240041
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.