# KLT: Enzyme Immunoassay, Carbamazepine

- Device class: 2; regulation: 21 CFR 862.3645; FDA's rule: 510(k) required
- FDA decisions: 56
- Recalls: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1998: 1
- 2000: 4
- 2001: 1
- 2002: 1
- 2003: 1
- 2005: 1
- 2007: 1
- 2011: 1
- 2013: 1
- 2015: 1

## Most-cited predicates
- K850807: Cobas FP Reagents for Carbamazepine (1985), cited by 1
- K913066: Emit (R) 2000 Carbamazepine Assay/Calibrators (1991), cited by 1
- K031902: Online TDM Carbamazepine (2003), cited by 1
- K010814: Emit 2000 Carbamazepine Assay, Model OSR4F229 (2001), cited by 1
- K955644: Synchron Systems Carbamazepine Test System (1996), cited by 1
- K955100: Carbamazepine Eia Test (1995), cited by 1
- K914857: Cedia (R) Carbamazepine Assay (1992), cited by 1
- K935374: Axsym Carbamazephine (1994), cited by 1
- K993028: Abbott Aeroset Carbamazepine Assay and Calibrators; Models 1E12 and 6E90 (2000), cited by 1
- K962820: Carbamazepine Flex Reagent Cartridge (1996), cited by 1

Source page: https://510kreport.com/product-code/KLT
Data by year (CSV): https://510kreport.com/product-code/KLT.csv