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510(k) K902678

LIQUID STABLE CHOLESTEROL REAGENT KIT by Trace Scientific , Ltd. — Product Code CHH

K902678 is an FDA 510(k) premarket notification submitted by Trace Scientific , Ltd. for the device "LIQUID STABLE CHOLESTEROL REAGENT KIT". The FDA issued a decision of Substantially Equivalent on September 25, 1990. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Trace Scientific , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1990
Date Received
June 19, 1990
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 Trace Scientific , Ltd.

  • K982121 — ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT (September 17, 1998)
  • K981123 — UREA (April 24, 1998)
  • K962890 — CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST) (September 27, 1996)
  • K961114 — AST INCORPORATING DST (May 23, 1996)
  • K961123 — ALT INCORPORATING DST (April 25, 1996)
  • K952488 — TRACE COBAS MIRA RANGE (October 13, 1995)
  • K932713 — TRACE TRANSFERRIN REAGENT (September 30, 1993)
  • K923322 — TRACE ALBUMIN-MR REAGENT (September 11, 1992)
  • K914731 — TRACE GAMMA GT-SS REAGENT (November 19, 1991)
  • K911866 — TRACE TOTAL/DIRECT BILIRUBIN REAGENT (July 17, 1991)

Other clearances for product code CHH

  • K251091 — Lipids (December 30, 2025)
  • 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)

FDA data resources