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510(k) K162593

HDL-Cholesterol Gen.4 by Roche Diagnostics Operations (Rdo) — Product Code LBS

K162593 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Operations (Rdo) for the device "HDL-Cholesterol Gen.4". The FDA issued a decision of Substantially Equivalent on October 19, 2016. The device falls under product code LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, 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
October 19, 2016
Date Received
September 16, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, 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)
  • 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)
  • K151578 — Carbamazepine Gen 4 (October 22, 2015)

Other clearances for product code LBS

  • K153435 — Direct HDL Cholesterol (HDL) (January 8, 2016)
  • K132711 — CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT (May 8, 2014)
  • K120609 — VITROS CHEMISTRY PRODUCTS DHDL SLIDES (September 7, 2012)
  • K111516 — NMR LIPOPROFILE (R) TEST AND NMR PROFILER (September 27, 2011)
  • K103747 — ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL (August 31, 2011)
  • K111036 — EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT (July 12, 2011)
  • K100550 — POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-C (September 28, 2010)
  • K100010 — HDL CHOLESTEROL (HDLX) ASSAY (May 14, 2010)
  • K080125 — APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 (July 18, 2008)
  • K073497 — HDL CHOLESTEROL REAGENT, MODEL 10211 (April 14, 2008)

FDA data resources