LDLC3 LDL-Cholesterol Gen.3— 510(k) K143691
Substantially EquivalentRoche Diagnostics Operations (Rdo)
FDA 510(k) clearance K143691 for LDLC3 LDL-Cholesterol Gen.3, Substantially Equivalent on 2015-01-28. Applicant: Roche Diagnostics Operations (Rdo). Device class: 1.
Clearance details
- Applicant
- Roche Diagnostics Operations (Rdo)
- Product code
- Code LBR
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code LBR
view all- K072523 — DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS
- K050823 — DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR
- K023784 — RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER
- K012593 — VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
- K992029 — ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
More clearances from Roche Diagnostics Operations (Rdo)
view allData sourced from openFDA. This site is unofficial and independent of the FDA.