# K011289: Emit II Plus Opiate Assay, Model OSR9B229

- Pathway: 510(k) (Special)
- Applicant: Syva Co., Dade Behring, Inc.
- Decided: May 15, 2001 after 18 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K062460: Vitros Chemistry Products OP Reagent, Calibrator Kit 26 and Dat Performance Verifiers I, II and Iii (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K011289
Methodology: https://510kreport.com/methodology