# K010934: Emit II Plus Barbituate Assay, Model 0SR9D0229

- Pathway: 510(k) (Special)
- Applicant: Syva Co., Dade Behring, Inc.
- Decided: Apr 20, 2001 after 23 days
- Product code: DIS (Enzyme Immunoassay, Barbiturate)
- Device class: 2
- Regulation: 21 CFR 862.3150
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K032764: Barbiturate Enzyme Immunoassay, CA. # 0140 (500 Tests Kit); Cat# 0141 (5000 Tests Kit) (2003), 1 descendant of its own
- K033885: BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit) (2004), 0 descendants of its own

Source page: https://510kreport.com/device/K010934
Methodology: https://510kreport.com/methodology