FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOTAL PROTEIN OR TP
K Number: K971524
·
Decision May 16, 1997
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
115
Applicant Total
20
Review Days
18
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Basic Information
- Device Name
- TOTAL PROTEIN OR TP
- K Number
- K971524
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1635
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Carolina Liquid Chemistries Corp.
- Date Received
- April 28, 1997
- Decision Date
- May 16, 1997
- Product Code
- CEK
- 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 |
|---|---|---|---|
| CEK | Biuret (Colorimetric), Total Protein | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CEK), ordered by most recent decision date.
HICHEM TOTAL PROTEIN REAGENT
FDA 510(k)
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TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50
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FDA Class 2
·Clinical Chemistry
CARESIDE TOTAL PROTEIN
FDA 510(k)
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·Clinical Chemistry
CSF/URINE TOTAL PROTEIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TOTAL PROTEIN REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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 |
| K971345 | CHOL OR CHOLESTEROL | May 29, 1997 | Substantially Equivalent |