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510(k) K143691

LDLC3 LDL-Cholesterol Gen.3 by Roche Diagnostics Operations (Rdo) — Product Code LBR

K143691 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Operations (Rdo) for the device "LDLC3 LDL-Cholesterol Gen.3". The FDA issued a decision of Substantially Equivalent on January 28, 2015. The device falls under product code LBR (Ldl & Vldl Precipitation, Hdl), a Class I device regulated under 21 CFR 862.1475. Roche Diagnostics Operations (Rdo) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2015
Date Received
December 24, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ldl & Vldl Precipitation, Hdl
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

Other clearances by Roche Diagnostics Operations (Rdo)

  • K193053 — Tina-quant Hemoglobin A1cDx Gen.3 (March 26, 2020)
  • K192072 — Tina-quant C-Reactive Protein IV (February 21, 2020)
  • K183517 — Ammonia II (February 8, 2019)
  • K182095 — Tina-quant Transferrin ver.2 (urine application) (November 5, 2018)
  • K171080 — ALP IFCC Gen.2 (May 10, 2017)
  • K160571 — cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay (December 19, 2016)
  • K162593 — HDL-Cholesterol Gen.4 (October 19, 2016)
  • K161817 — Tina-quant Cystatin C Gen.2 (July 27, 2016)
  • K160570 — Creatine Kinase (May 25, 2016)
  • K152245 — ONLINE TDM Vancomycin Gen.3 (January 8, 2016)

Other clearances for product code LBR

  • K072523 — DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS (January 22, 2008)
  • K050823 — DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR (July 26, 2005)
  • K023784 — RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA (December 24, 2002)
  • K012593 — VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRO (August 30, 2001)
  • K992029 — ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS (August 12, 1999)
  • K992002 — AUTOHDL CHOLESTEROL REAGENT SET (August 5, 1999)
  • K991789 — ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS (July 9, 1999)
  • K990247 — MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 (May 28, 1999)
  • K984303 — VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT (January 28, 1999)
  • K980772 — HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51 (April 27, 1998)

FDA data resources