# K905689: Cedia Phenytoin Assay

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: Jan 17, 1991 after 29 days
- Product code: DIP (Enzyme Immunoassay, Diphenylhydantoin)
- Device class: 2
- Regulation: 21 CFR 862.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K963840: Cedia Phenytoin II Assay (1996), 1 descendant of its own
- K961659: Cedia Core TDM Multi-Cal (1996), 1 descendant of its own
- K120936: Abbott TDM Multiconstituent Calibrator, Thermo Scientific QMS Multi-Constituent Calibrators (2012), 0 descendants of its own
- K030428: Roche Online TDM Phenytoin (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K905689
Methodology: https://510kreport.com/methodology