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510(k) K943599

CHEM TRAK ACCUMETER by Chemtrak, Inc. — Product Code CHH

K943599 is an FDA 510(k) premarket notification submitted by Chemtrak, Inc. for the device "CHEM TRAK ACCUMETER". The FDA issued a decision of Substantially Equivalent on March 21, 1995. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Chemtrak, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1995
Date Received
July 6, 1994
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 Chemtrak, Inc.

  • K972495 — ACCUMETER THEOPHYLLINE TEST (October 10, 1997)
  • K965099 — ACCUMETER H. PYLORI TEST (February 20, 1997)
  • K960478 — ACCUMETER H. PYLORI TEST (June 27, 1996)
  • K943279 — ACCUMETER HDL CHOLESTEROL TEST (May 1, 1995)
  • K914432 — ACCUMETER(R) CHOLESTEROL SELF-TEST (March 2, 1993)
  • K905405 — CHEMTRAK ACCUMETER CHOLESTEROL TEST (March 19, 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