# K962519: Emit 2000 Gentamicin Assay and Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: Sep 4, 1996 after 69 days
- Product code: LCD (Enzyme Immunoassay, Gentamicin)
- Device class: 2
- Regulation: 21 CFR 862.3450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K904226 (1990). 1 ancestor in all.
1 later device descends 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)
- K904226: 'Tdxflx Analyzer, Abbott Laboratories (1990) Summary page 1.

## Most influential descendants
- K042479: Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros Chemistyr Products Calibrator Kits 11, 13 & 14; Vitros Che (2005), 0 descendants of its own

## Indications for use
an in vitro diagnostic reagent test kit for the quantitative analysis of gentamicin in human serum or plasma.

Source page: https://510kreport.com/device/K962519
Methodology: https://510kreport.com/methodology