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510(k) K823784

ENZYMATIC CHOLESTEROL (COLORIMETRIC by Analytical & Research Chemicals, Inc. — Product Code CHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1983
Date Received
December 16, 1982
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 Analytical & Research Chemicals, Inc.

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  • K823786 — ALKALINE PHOSPHATASE (January 14, 1983)
  • K781441 — BCG ALBUMIN REAGET (October 10, 1978)
  • K781460 — CHLORIDE REAGENT (October 10, 1978)
  • K781323 — LDH PROCEDURE (August 31, 1978)
  • K781306 — UREA NITROGEN TEST KIT (August 31, 1978)
  • K781307 — GLUCOSE DETERM. KIT (August 31, 1978)
  • K781308 — GLUCOLOUR (August 31, 1978)
  • K781305 — UREA NITROGEN (August 31, 1978)
  • K781324 — ALP TEST (August 31, 1978)

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)