FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHOL OR CHOLESTEROL
K Number: K971345
·
Decision May 29, 1997
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
229
Applicant Total
20
Review Days
49
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Basic Information
- Device Name
- CHOL OR CHOLESTEROL
- K Number
- K971345
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Carolina Liquid Chemistries Corp.
- Date Received
- April 10, 1997
- Decision Date
- May 29, 1997
- Product Code
- CHH
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | FDA class 1 | Clinical Chemistry |
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Other Clearances by Carolina Liquid Chemistries Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K213211 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System | Jan 27, 2022 | Substantially Equivalent |
| 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 |
| K971396 | CK REAGENT | May 29, 1997 | Substantially Equivalent |