Carolina Liquid Chemistries
FDA Regulatory Profile
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 20
- Inspections
- 10
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1701-2020 | Class II | SPICE (JWH-018) CC443 | February 10, 2020 |
| Z-1743-2020 | Class II | Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent | January 20, 2020 |
| Z-1253-2019 | Class III | CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321 | January 16, 2019 |
| Z-1252-2019 | Class III | CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321 | January 16, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K213211 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System | January 27, 2022 |
| K133519 | CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGEN | May 16, 2014 |
| K132711 | CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT | May 8, 2014 |
| K971907 | CALCIUM REAGENT | June 24, 1997 |
| K972073 | TOTAL BILIRUBIN REAGENT | June 24, 1997 |
| K971324 | TRIGLYCERIDES, TG, OR TRIG | June 20, 1997 |
| K971908 | CREA OR CREATININE | June 17, 1997 |
| K971967 | BUN | June 17, 1997 |
| K971467 | SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU) | June 16, 1997 |
| K971396 | CK REAGENT | May 29, 1997 |
| K971345 | CHOL OR CHOLESTEROL | May 29, 1997 |
| K971463 | ALP REAGENT SET | May 16, 1997 |
| K971524 | TOTAL PROTEIN OR TP | May 16, 1997 |
| K971466 | SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT) | May 6, 1997 |
| K971398 | LD-L REAGENT | May 2, 1997 |
| K971445 | ALB OR ALBUMIN | May 2, 1997 |
| K971363 | SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT | April 21, 1997 |
| K971323 | ALT OR SGPT | April 21, 1997 |
| K971344 | AST OR SGOT | April 21, 1997 |
| K971133 | URIC, UA, OR URIC ACID | April 14, 1997 |