# K913066: Emit (R) 2000 Carbamazepine Assay/Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Syva Co.
- Decided: Jul 30, 1991 after 20 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
- K993028: Abbott Aeroset Carbamazepine Assay and Calibrators; Models 1E12 and 6E90 (2000), 1 descendant of its own
- K123518: Abbott Carbamazepine Assay (2013), 0 descendants of its own

Source page: https://510kreport.com/device/K913066
Methodology: https://510kreport.com/methodology