# K073080: Quest Diagnostics Serum Chemistry Control, Models 935 and 945

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories
- Decided: Jan 24, 2008 after 85 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: 3 generations back to K923633 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033387: Quest Diagnostics Serum Chemistry Control, Models 935 and 945, Bio-Rad (2003) Summary page 1.

## Indications for use
Quest Diagnostics Serum Chemistry Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

Source page: https://510kreport.com/device/K073080
Methodology: https://510kreport.com/methodology