# K132711: Carolina Liquid Chemistries HDL Cholesterol Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Carolina Liquid Chemistries Corp.
- Decided: May 8, 2014 after 252 days
- Product code: LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl)
- Device class: 1
- Regulation: 21 CFR 862.1475
- 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. The FDA summary names no predicate by number.

## Indications for use
For the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in serum using the Carolina Liquid Chemistries CLC7200) Clinical Chemistry Analyzer. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K132711
Methodology: https://510kreport.com/methodology