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510(k) K950164

PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR by Abaxis, Inc. — Product Code CHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1995
Date Received
January 17, 1995
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

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  • K120662 — PICCOLO HDL-CAPILLARY TEST SYSTEM (April 24, 2012)
  • K091052 — PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM (January 15, 2010)
  • K091910 — PICCOLO MAGNESIUM TEST SYSTEM (October 1, 2009)
  • K051108 — PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM (July 8, 2005)
  • K040115 — PICCOLO MAGNESIUM TEST SYSTEM (January 30, 2004)
  • K023642 — PICCOLO TOTAL CHOLESTEROL TEST SYSTEM (January 24, 2003)

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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)
  • K132031 — AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL (March 21, 2014)