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510(k) K132031

AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL by Axis-Shield Poc AS — Product Code CHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2014
Date Received
July 18, 2013
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 Axis-Shield Poc AS

  • K110056 — AFINION ANALYZER (February 15, 2011)
  • K072409 — AFINION ACR AND ACR CONTROL (February 12, 2008)
  • K050574 — AFINION HBALC (July 22, 2005)

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  • K190490 — VITROS XT Chemistry Products TRIG-CHOL Slides (March 27, 2019)
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  • 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)
  • K130200 — PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM (February 15, 2013)