# K033387: Quest Diagnostics Serum Chemistry Control, Models 935 and 945

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Dec 2, 2003 after 40 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 K923633 (1992). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011867: Liquid Assayed Multiqual Control LEVEL1 #981600; Level 2 #981700; Level 3 #981800, Bio-Rad (2001) Summary page 1.

## Most influential descendants
- K073080: Quest Diagnostics Serum Chemistry Control, Models 935 and 945 (2008), 0 descendants of its own

## Indications for use
For use as a quality control serum to monitor the precision of an individual laboratory's automated and manual-testing procedures.

Source page: https://510kreport.com/device/K033387
Methodology: https://510kreport.com/methodology