510(k) Report

FDA applicant

Carolina Liquid Chemistries Corp.

Brea, CA21 decisions1997–20220 recalls

FDA records 21 decisions for Carolina Liquid Chemistries Corp. (Brea, CA) from 1997 to 2022: 21 510(k) clearances. Most are in product codes DIO (Enzyme Immunoassay, Cocaine And Cocaine…) and JQB (Kinetic Method, Gamma-Glutamyl Transpeptidase). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Carolina Liquid Chemistries Corporation”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Carolina Liquid Chemistries Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2014: 22017: 12022: 1
2007high 2 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Carolina Liquid Chemistries Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Carolina Liquid Chemistries Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites2decisions
  • JQBKinetic Method, Gamma-Glutamyl Transpeptidase1decision
  • CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes1decision
  • LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl1decision
  • CITNadh Oxidation/Nad Reduction, Ast/Sgot1decision
  • KNKAcid, Uric, Uricase (Colorimetric)1decision

Also: CGX (1), CGS (1), CEO (1), CDT (1), JJE (1), CHH (1).

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K971324Triglycerides, TG, or TrigCarolina Liquid Chemistries Corp. · 19971cites it

What has FDA decided for it lately?

  • K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test SystemCarolina Liquid Chemistries Corp. · 2022
  • K163570Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)Carolina Liquid Chemistries Corporation · 2017
  • K133519Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer; Carolina Liquid Chemistries Glucose Reagent, CarCarolina Liquid Chemistries Corp. · 2014
  • K132711Carolina Liquid Chemistries HDL Cholesterol ReagentCarolina Liquid Chemistries Corp. · 2014
  • K972073Total Bilirubin ReagentCarolina Liquid Chemistries Corp. · 1997
  • K971907Calcium ReagentCarolina Liquid Chemistries Corp. · 1997
  • K971324Triglycerides, TG, or TrigCarolina Liquid Chemistries Corp. · 1997
  • K971908Crea or CreatinineCarolina Liquid Chemistries Corp. · 1997

All 20 as Carolina Liquid Chemistries Corp. →The one decision as Carolina Liquid Chemistries Corporation →