# K060850: Nod Chemistry Control

- Pathway: 510(k) (Traditional)
- Applicant: Bioresource Technology, Inc.
- Decided: May 30, 2006 after 63 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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 NODTM Chemistry Control is a two-level control set that is intended for in-vitro diagnostic use to monitor the precision of laboratory testing procedures for the analytes listed in the package insert (routine chemistries).

Source page: https://510kreport.com/device/K060850
Methodology: https://510kreport.com/methodology