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510(k) K946064

TOTAL CHOLESTEROL CASSETTE by Cholestech Corp. — Product Code CHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1995
Date Received
November 15, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic Esterase--Oxidase, Cholesterol
Device Class
Class I
Regulation Number
862.1175
Review Panel
CH
Submission Type

Other clearances by Cholestech Corp.

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  • 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)
  • K946066 — TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANEL (February 22, 1995)
  • K946067 — TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANEL (February 22, 1995)
  • K946065 — TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL (February 22, 1995)
  • K946063 — TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL (February 22, 1995)
  • K932727 — CHOLESTECH L.D.X. SYSTEM (November 9, 1993)

Other clearances for product code CHH

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  • K181373 — Extended Lipid Panel Assay (October 18, 2018)
  • K180504 — Mission Lipid Panel Monitoring System (March 28, 2018)
  • K163406 — Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System (July 11, 2017)
  • K151545 — CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test Sys (December 22, 2016)
  • K150654 — Cholesterol (September 29, 2015)
  • K132031 — AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL (March 21, 2014)