# K955434: Access Folate Assay (Modification)

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jan 29, 1996 after 119 days
- Product code: CGN (Acid, Folic, Radioimmunoassay)
- Device class: 2
- Regulation: 21 CFR 862.1295
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K060774: Folate on the Access Immunoassay Systems, Model A14208 (2006), 7 descendants of its own
- K090588: Power Processor Sample Processing System with Generic Connection Module, Model: 4210 (2009), 4 descendants of its own
- K110413: Power Processor Sample Processing System with Generic Connections (2011), 3 descendants of its own
- K140496: Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents (2014), 1 descendant of its own
- K111952: Access Folate Calibrators on the Access Immunoassay Systems Model A98033 (2011), 1 descendant of its own

Source page: https://510kreport.com/device/K955434
Methodology: https://510kreport.com/methodology