Carolina Liquid Chemistries
Brea, CA, US
Carolina Liquid Chemistries appears in FDA device records in Brea, CA. FDA records list 21 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 21 510(k) clearances for Carolina Liquid Chemistries between 1997 and 2022. The busiest year on record is 1997, with 17. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 17 |
| 2014 | 2 |
| 2017 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K213211 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System | DIO | Substantially Equivalent | |
| K163570 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) | DIO | Substantially Equivalent | |
| K133519 | CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR | JJE | Substantially Equivalent | |
| K132711 | CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT | LBS | Substantially Equivalent | |
| K972073 | TOTAL BILIRUBIN REAGENT | CIG | Substantially Equivalent | |
| K971907 | CALCIUM REAGENT | CIC | Substantially Equivalent | |
| K971324 | TRIGLYCERIDES, TG, OR TRIG | CDT | Substantially Equivalent | |
| K971967 | BUN | CDQ | Substantially Equivalent | |
| K971908 | CREA OR CREATININE | CGX | Substantially Equivalent | |
| K971467 | SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU) | CFR | Substantially Equivalent | |
| K971396 | CK REAGENT | CGS | Substantially Equivalent | |
| K971345 | CHOL OR CHOLESTEROL | CHH | Substantially Equivalent | |
| K971524 | TOTAL PROTEIN OR TP | CEK | Substantially Equivalent | |
| K971463 | ALP REAGENT SET | CJE | Substantially Equivalent | |
| K971466 | SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT) | JQB | Substantially Equivalent | |
| K971445 | ALB OR ALBUMIN | CIX | Substantially Equivalent | |
| K971398 | LD-L REAGENT | CFJ | Substantially Equivalent | |
| K971363 | SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT | CEO | Substantially Equivalent | |
| K971344 | AST OR SGOT | CIT | Substantially Equivalent | |
| K971323 | ALT OR SGPT | CKA | Substantially Equivalent | |
| K971133 | URIC, UA, OR URIC ACID | KNK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2030861 | 3000215862 | Carolina Liquid Chemistries | 510 W Central Ave Ste C, Brea, CA 92821 US | 2026 | and 47 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KNKAcid, Uric, Uricase (Colorimetric)
- DCFAlbumin, Antigen, Antiserum, Control
- DKCAlcohol Control Materials
- DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- CGXAlkaline Picrate, Colorimetry, Creatinine
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- LCPAssay, Glycosylated Hemoglobin
- CJYAzo Dye, Calcium
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- CJWBromcresol Purple Dye-Binding, Albumin
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- JIXCalibrator, Multi-Analyte Mixture
- JISCalibrator, Primary
- JITCalibrator, Secondary
- DKBCalibrators, Drug Mixture
- DLJCalibrators, Drug Specific
- DNNCalibrators, Ethyl Alcohol
- JFJCatalytic Methods, Amylase
- JPZColorimetric Method, Gamma-Glutamyl Transpeptidase
- CICCresolphthalein Complexone, Calcium
- JCBDetergent
- CIGDiazo Colorimetry, Bilirubin
- DIFDrug Mixture Control Materials
- LASDrug Specific Control Materials
- JFPElectrode, Ion Specific, Calcium
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- CGZElectrode, Ion-Specific, Chloride
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- DMTEnzymatic Method, Alcohol Dehydrogenase, Ultraviolet
- KHSEnzymatic, Carbon-Dioxide
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJREnzyme Immunoassay, Methadone
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- JXNEnzyme Immunoassay, Propoxyphene
- KHOFluorometer, For Clinical Use
- LAFGas Chromatography, Methamphetamine
- CFRHexokinase, Glucose
- JQBKinetic Method, Gamma-Glutamyl Transpeptidase
- LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- JQYPh Meter
- JFLPh Rate Measurement, Carbon-Dioxide
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JGJPhotometric Method, Magnesium
- KSLSolution, Copper Sulfate For Specific Gravity Determinations
- MRRSystem, Test, Low Density, Lipoprotein
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1701-2020 | SPICE (JWH-018) CC443 | Corrections are being made to the device labeling regarding its intended use, to include a statement clarifying it is for research purposes only. | Class II | Terminated | |
| Z-1743-2020 | Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent | 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 | Class II | Terminated | |
| Z-1253-2019 | CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321 | 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. | Class III | Terminated | |
| Z-1252-2019 | CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321 | Class III | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain