Company ยท US
Carolina Liquid Chemistries Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2022. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DIC | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | 2 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 2 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 |
| CFR | Hexokinase, Glucose | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 |
| DJG | Enzyme Immunoassay, Opiates | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 |
| JQB | Kinetic Method, Gamma-Glutamyl Transpeptidase | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 27, 2022 | K213211 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System Carolina Liquid Chemistries Corp. | DIO |
| Aug 15, 2017 | K163570 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) Carolina Liquid Chemistries Corporation | DIO |
| May 16, 2014 | K133519 | CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR Carolina Liquid Chemistries Corp. | JJE |
| May 8, 2014 | K132711 | CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT Carolina Liquid Chemistries Corp. | LBS |
| Jun 24, 1997 | K972073 | TOTAL BILIRUBIN REAGENT Carolina Liquid Chemistries Corp. | CIG |
| Jun 24, 1997 | K971907 | CALCIUM REAGENT Carolina Liquid Chemistries Corp. | CIC |
| Jun 20, 1997 | K971324 | TRIGLYCERIDES, TG, OR TRIG Carolina Liquid Chemistries Corp. | CDT |
| Jun 17, 1997 | K971967 | BUN Carolina Liquid Chemistries Corp. | CDQ |
| Jun 17, 1997 | K971908 | CREA OR CREATININE Carolina Liquid Chemistries Corp. | CGX |
| Jun 16, 1997 | K971467 | SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU) Carolina Liquid Chemistries Corp. | CFR |
| May 29, 1997 | K971396 | CK REAGENT Carolina Liquid Chemistries Corp. | CGS |
| May 29, 1997 | K971345 | CHOL OR CHOLESTEROL Carolina Liquid Chemistries Corp. | CHH |
| May 16, 1997 | K971524 | TOTAL PROTEIN OR TP Carolina Liquid Chemistries Corp. | CEK |
| May 16, 1997 | K971463 | ALP REAGENT SET Carolina Liquid Chemistries Corp. | CJE |
| May 6, 1997 | K971466 | SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT) Carolina Liquid Chemistries Corp. | JQB |
| May 2, 1997 | K971445 | ALB OR ALBUMIN Carolina Liquid Chemistries Corp. | CIX |
| May 2, 1997 | K971398 | LD-L REAGENT Carolina Liquid Chemistries Corp. | CFJ |
| Apr 21, 1997 | K971363 | SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT Carolina Liquid Chemistries Corp. | CEO |
| Apr 21, 1997 | K971344 | AST OR SGOT Carolina Liquid Chemistries Corp. | CIT |
| Apr 21, 1997 | K971323 | ALT OR SGPT Carolina Liquid Chemistries Corp. | CKA |
| Apr 14, 1997 | K971133 | URIC, UA, OR URIC ACID Carolina Liquid Chemistries Corp. | KNK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 10, 2020 | Carolina Liquid Chemistries Corp SPICE (JWH-018) CC443 Terminated |
LDJ | None listed |
| Jan 20, 2020 | Carolina Liquid Chemistries Corp Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent Terminated |
DJG | None listed |
| Jan 16, 2019 | Carolina Liquid Chemistries CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321 Terminated |
DIC | K032461 |
| Jan 16, 2019 | Carolina Liquid Chemistries CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321 Terminated |
DIC | K032461 |