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510(k) K971345

CHOL OR CHOLESTEROL by Carolina Liquid Chemistries Corp. — Product Code CHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1997
Date Received
April 10, 1997
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 Carolina Liquid Chemistries Corp.

  • K213211 — Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (C (January 27, 2022)
  • K133519 — CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMIS (May 16, 2014)
  • K132711 — CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT (May 8, 2014)
  • K972073 — TOTAL BILIRUBIN REAGENT (June 24, 1997)
  • K971907 — CALCIUM REAGENT (June 24, 1997)
  • K971324 — TRIGLYCERIDES, TG, OR TRIG (June 20, 1997)
  • K971967 — BUN (June 17, 1997)
  • K971908 — CREA OR CREATININE (June 17, 1997)
  • K971467 — SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU) (June 16, 1997)
  • K971396 — CK REAGENT (May 29, 1997)

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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)