# K123775: Liquichek Spinal Fluid Control Level 1, Liquichek Spinal Fluid Control Level 2, Liquichek Spinal Fluid Control Minipak

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories
- Decided: Jan 31, 2013 after 52 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 K932076 (1993). 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)
- K990888: Modification to Liquichek Spinal Fluid Control, Item Nos. 751, 752, Bio-Rad (1999) Summary page 1.

## Indications for use
Liquichek Spinal Fluid Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in this package insert. The following analytes are listed in the package insert: > Albumin > Chloride > Glucose > Immunoglobulin G (IgO) > Lactate (Lactic Acid) > Lactate Dehydrogenase (LDH) > Protein Total > Sodium

Source page: https://510kreport.com/device/K123775
Methodology: https://510kreport.com/methodology