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510(k) K842441

AXIOM STABLE II CHOLESTEROL TEST by Axiom, Inc. — Product Code CHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1984
Date Received
June 21, 1984
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 Axiom, Inc.

  • K883887 — AXIOM ATRAUM WOUND DRAINS (February 17, 1989)
  • K842443 — AXIOM STABLE II TRIGLYCERIDES TEST (September 13, 1984)
  • K842442 — AXIOM STABLE II URIC ACID TEST (August 16, 1984)

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  • 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)