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510(k) K905296

CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL by Cholestech Corp. — Product Code LBS

K905296 is an FDA 510(k) premarket notification submitted by Cholestech Corp. for the device "CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL". The FDA issued a decision of Substantially Equivalent on December 26, 1990. 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. Cholestech Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 26, 1990
Date Received
November 27, 1990
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 Cholestech Corp.

  • K040579 — CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) (June 18, 2004)
  • K032027 — CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) (September 5, 2003)
  • K991834 — CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 (September 9, 1999)
  • K972012 — CHOLESTECH BUN/CREATININE TEST SYSTEM (July 24, 1997)
  • K954778 — CHOLESTECH LDX SYSTEM (November 24, 1995)
  • K946064 — TOTAL CHOLESTEROL CASSETTE (February 22, 1995)
  • K946063 — TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL (February 22, 1995)
  • K946065 — TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL (February 22, 1995)
  • K946067 — TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANEL (February 22, 1995)
  • K946066 — TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANEL (February 22, 1995)

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