Class Class II
Access AMH (K223679)
Description
Access AMH by Beckman Coulter, Inc., an FDA 510(k) cleared clinical chemistry device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223679
Clearance Date2023-02-03
Clearance TypeTraditional
Product CodePQO
Regulation Number862.1092
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223679
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 AMH (K223679) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K170524 | Access AMH | Beckman Coulter, Inc. | 2017 |
Trace the full predicate network for K223679
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.