# K983280: Vancomycin Eia Assay

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Reagents, Inc.
- Decided: Nov 6, 1998 after 49 days
- Product code: LEH (Radioimmunoassay, Vancomycin)
- Device class: 2
- Regulation: 21 CFR 862.3950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Vancomycin Enzyme Immunoassay is intended for in vitro diagnostic use for quantitative determination of vancomycin in human serum or plasma.

Source page: https://510kreport.com/device/K983280
Methodology: https://510kreport.com/methodology