Carolina Liquid Chemistries Corp.: FDA clearances and approvals
Carolina Liquid Chemistries Corp. has 21 FDA 510(k) clearances (first 1997, latest 2022), across 20 product codes in 2 review panels. Median 510(k) review time: 25 days. openFDA lists 4 product recalls by a recalling firm named Carolina Liquid Chemistries Corp.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 2 | 217 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 239 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 120 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Carolina Liquid Chemistries Corp.'s cleared 510(k)s took a median 180 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 239 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 2 | 2 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 | 1 |
| CFR | Hexokinase, Glucose | 1 | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
Plus 10 more product codes.
Review panels
Most recent Carolina Liquid Chemistries Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213211 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System | DIO | 2022-01-27 | 120 |
| K163570 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) | DIO | 2017-08-15 | 239 |
| K133519 | CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR | JJE | 2014-05-16 | 182 |
| K132711 | CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT | LBS | 2014-05-08 | 252 |
| K972073 | TOTAL BILIRUBIN REAGENT | CIG | 1997-06-24 | 21 |
| K971907 | CALCIUM REAGENT | CIC | 1997-06-24 | 32 |
| K971324 | TRIGLYCERIDES, TG, OR TRIG | CDT | 1997-06-20 | 71 |
| K971967 | BUN | CDQ | 1997-06-17 | 20 |
| K971908 | CREA OR CREATININE | CGX | 1997-06-17 | 25 |
| K971467 | SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU) | CFR | 1997-06-16 | 55 |
11 earlier clearances. See the full list in Caduvo.
Recalls
4 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2020-02-10.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Carolina Liquid Chemistries Corp. have?
Carolina Liquid Chemistries Corp. has 21 FDA 510(k) clearances (first 1997, latest 2022), across 20 product codes in 2 review panels.
How long does FDA take to clear Carolina Liquid Chemistries Corp.'s 510(k)s?
The median time from FDA receipt to decision across Carolina Liquid Chemistries Corp.'s cleared 510(k)s is 25 days.
What devices does Carolina Liquid Chemistries Corp. make?
Its most frequent FDA product codes are DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites, 2); CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen, 1); CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, 1).
Has Carolina Liquid Chemistries Corp. had device recalls?
openFDA lists 4 product recalls in 3 recall events by a recalling firm whose name matches Carolina Liquid Chemistries Corp; the most recent began 2020-02-10. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 21 Carolina Liquid Chemistries Corp. clearances with predicates and recalls
- Run predicate analysis for product code DIO, Carolina Liquid Chemistries Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.