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510(k) K863064

CHOLESTEROL-E (FREE) by J. D. Assoc. — Product Code CHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1986
Date Received
August 12, 1986
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 J. D. Assoc.

  • K863054 — AST S.C.E. (GOT) (January 13, 1987)
  • K863103 — PEG 6,000 (January 13, 1987)
  • K863069 — MAGNESIOMETER (December 31, 1986)
  • K863079 — CREATINKINETIC (December 12, 1986)
  • K863068 — LDH S.C.E. (December 10, 1986)
  • K863112 — PROTEINMETER (December 10, 1986)
  • K863053 — ALT S.C.E. (GPT) (December 10, 1986)
  • K863066 — TRANSFERMETER (December 4, 1986)
  • K863109 — FERROFAST (November 24, 1986)
  • K863056 — BILIRUBIN TOTAL (November 24, 1986)

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  • K190490 — VITROS XT Chemistry Products TRIG-CHOL Slides (March 27, 2019)
  • 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)