FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System
K Number: K213211
·
Decision Jan 27, 2022
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
144
Applicant Total
20
Review Days
120
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Basic Information
- Device Name
- Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System
- K Number
- K213211
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3250
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Carolina Liquid Chemistries Corp.
- Date Received
- September 29, 2021
- Decision Date
- January 27, 2022
- Product Code
- DIO
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | FDA class 2 | Clinical Toxicology |
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Other Clearances by Carolina Liquid Chemistries Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K133519 | CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR | May 16, 2014 | Substantially Equivalent |
| K132711 | CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT | May 8, 2014 | Substantially Equivalent |
| K972073 | TOTAL BILIRUBIN REAGENT | Jun 24, 1997 | Substantially Equivalent |
| K971907 | CALCIUM REAGENT | Jun 24, 1997 | Substantially Equivalent |
| K971324 | TRIGLYCERIDES, TG, OR TRIG | Jun 20, 1997 | Substantially Equivalent |
| K971967 | BUN | Jun 17, 1997 | Substantially Equivalent |
| K971908 | CREA OR CREATININE | Jun 17, 1997 | Substantially Equivalent |
| K971467 | SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU) | Jun 16, 1997 | Substantially Equivalent |
| K971345 | CHOL OR CHOLESTEROL | May 29, 1997 | Substantially Equivalent |
| K971396 | CK REAGENT | May 29, 1997 | Substantially Equivalent |