# K031644: Bayer Advia Chemistry Special Chemistry Control

- Pathway: 510(k) (Abbreviated)
- Applicant: Bayer Healthcare, LLC
- Decided: Jun 25, 2003 after 29 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
Longest line of descent: 2 generations back to K023840 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030801: Bayer Advia 1650 Special Chemistry Control, Bayer Healthcare, LLC (2003)

## Indications for use
For in vitro diagnostic use in the control of ADVIA Chemistry systems for certain chemistry methods.

Source page: https://510kreport.com/device/K031644
Methodology: https://510kreport.com/methodology