# K914857: Cedia (R) Carbamazepine Assay

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: Jan 15, 1992 after 78 days
- Product code: KLT (Enzyme Immunoassay, Carbamazepine)
- Device class: 2
- Regulation: 21 CFR 862.3645
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- 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

Source page: https://510kreport.com/device/K914857
Methodology: https://510kreport.com/methodology