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Carolina Liquid Chemistries Corp.

Last updated September 17, 2026

Information

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Device	Model / Reference	Registries	Class	Status
Synchron Cx Systems Phosphorus Reagent	K971363	FDA 510(k)	Class I	Active
Carolina Liquid Chemistries Hdl Cholesterol Reagent	K132711	FDA 510(k)	Class I	Active
Crea Or Creatinine	K971908	FDA 510(k)	Class II	Active
Chol Or Cholesterol	K971345	FDA 510(k)	Class I	Active
Ck Reagent	K971396	FDA 510(k)	Class II	Active
Triglycerides, Tg, Or Trig	K971324	FDA 510(k)	Class I	Active
Bun	K971967	FDA 510(k)	Class II	Active
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)	K163570	FDA 510(k)	Class II	Active
Total Bilirubin Reagent	K972073	FDA 510(k)	Class II	Active
Uric, Ua, Or Uric Acid	K971133	FDA 510(k)	Class I	Active
Carolina Liquid Chemistries Clc 6410 Chemistry Analyzer; Carolina Liquid Chemistries Glucose Reagent, Car	K133519	FDA 510(k)	Class I	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Feb 10, 2020	Z-1701-2020	—	terminated	Corrections are being made to the device labeling regarding its intended use, to include a statement clarifying it is for research purposes only.
Jan 20, 2020	Z-1743-2020	—	terminated	Labeled for diagnostic use and sold to clinical labs without a 510(k). Firm corrected labeling to remove clinical diagnostic language and notified customers that products are labeled for "Forensic Use Only" and are not FDA Cleared and not to be used for clinical purposes
Jan 16, 2019	Z-1253-2019	—	terminated	Supplier testing showed that the absorbance rate of the Ethyl Alcohol Assay did not meet internal quality control specifications. The defective lots will not function toward the end of shelf life.
Jan 16, 2019	Z-1252-2019	—	terminated	—