Class Class II
Access 25(OH) Vitamin D Total (K223503)
Description
Access 25(OH) Vitamin D Total by Beckman Coulter, Inc., an FDA 510(k) cleared clinical chemistry device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223503
Clearance Date2023-01-19
Clearance TypeTraditional
Product CodeMRG
Regulation Number862.1825
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223503
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 25(OH) Vitamin D Total (K223503) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K142373 | Access 25(OH) Vitamin D Total for Use on the Access 2 Immu... | Beckman Coulter, Inc. | 2014 |
Trace the full predicate network for K223503
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.