# K963840: Cedia Phenytoin II Assay

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Nov 20, 1996 after 57 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
Longest line of descent: 1 generation back to K905689 (1991). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905689: Cedia Phenytoin Assay, Microgenics Corp. (1991) Summary page 1.

## Most influential descendants
- K030428: Roche Online TDM Phenytoin (2003), 0 descendants of its own

## Indications for use
Immunoassay for the in vitro quantitative determination of phenytoin in human serum and plasma.

Source page: https://510kreport.com/device/K963840
Methodology: https://510kreport.com/methodology