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510(k) K864159

SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD by Chem-Elec, Inc. — Product Code CHH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1988
Date Received
October 23, 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 Chem-Elec, Inc.

  • K943503 — CHEMCARD GLUCOSE TEST (July 23, 1996)
  • K811319 — CHLORIDE REAGENT KIT (August 13, 1981)
  • K811381 — ASTRA (August 13, 1981)
  • K811165 — GLUCOSE OXIDASE RATE REAGENT (August 13, 1981)
  • K811406 — CREATININE RATE REAGENT KIT (August 13, 1981)
  • K811310 — SODIUM/POTASSIUM REAGENT KITS (July 10, 1981)
  • K811193 — BUN RATE REAGENT (July 10, 1981)
  • K811701 — CHLORIDE/CARBON DIOXIDE RATE REAGENT (July 1, 1981)

Other clearances for product code CHH

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  • K232404 — CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES (August 9, 2024)
  • K203597 — Cholesterol2 (June 30, 2022)
  • 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)