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510(k) K050632

ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY by Bayer Healthcare, LLC — Product Code LBS

K050632 is an FDA 510(k) premarket notification submitted by Bayer Healthcare, LLC for the device "ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY". The FDA issued a decision of Substantially Equivalent on May 26, 2005. 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. Bayer Healthcare, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2005
Date Received
March 9, 2005
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 Bayer Healthcare, LLC

  • K171802 — ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) (March 7, 2018)
  • K152852 — ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) (December 22, 2015)
  • K150942 — Contour Next USB Blood Glucose Monitoring System (November 25, 2015)
  • K151742 — Contour Next Control Solution (September 23, 2015)
  • K130265 — CONTOUR NEXT EZ BLOOD GLUCOSE METER (June 23, 2014)
  • K122370 — CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR (September 26, 2013)
  • K121190 — CONTOUR NEXT BLOOD GLUCOSE METER (July 26, 2012)
  • K121087 — CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM (June 28, 2012)
  • K110894 — CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER (March 28, 2012)
  • K110587 — CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CON (March 28, 2012)

Other clearances for product code LBS

  • K162593 — HDL-Cholesterol Gen.4 (October 19, 2016)
  • 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)

FDA data resources