FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LDLC3 LDL-Cholesterol Gen.3
K Number: K143691
·
Decision Jan 28, 2015
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
65
Applicant Total
14
Review Days
35
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Basic Information
- Device Name
- LDLC3 LDL-Cholesterol Gen.3
- K Number
- K143691
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Operations (Rdo)
- Date Received
- December 24, 2014
- Decision Date
- January 28, 2015
- Product Code
- LBR
- 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 |
|---|---|---|---|
| LBR | Ldl & Vldl Precipitation, Hdl | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LBR), ordered by most recent decision date.
DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS
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RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER
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VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
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ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
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AUTOHDL CHOLESTEROL REAGENT SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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