Class Class II
Access PCT (K222996)
Description
Access PCT by Beckman Coulter, Inc., an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222996
Clearance Date2023-04-26
Clearance TypeTraditional
Product CodePTF
Regulation Number866.3215
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222996
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. Access PCT (K222996) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K192271 | Access PCT, Access PCT Calibrators | Beckman Coulter, Inc. | 2019 |
Trace the full predicate network for K222996
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.