# K944932: Phenobarbital Flex Reagent Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Dupont Medical Products
- Decided: Dec 28, 1994 after 83 days
- Product code: DLZ (Enzyme Immunoassay, Phenobarbital)
- Device class: 2
- Regulation: 21 CFR 862.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 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
- K051087: Dimension Vista Integrated System (2005), 5 descendants of its own
- K073561: Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator (2008), 1 descendant of its own
- K061838: Dimension Vista Chemistry 1 Calibrator, Model KC110 (2006), 1 descendant of its own
- K143720: Dimension Vista MMB Assay (2015), 0 descendants of its own
- K140790: Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG) (2015), 0 descendants of its own

Source page: https://510kreport.com/device/K944932
Methodology: https://510kreport.com/methodology