Home / 510(k) Clearances / K151545

510(k) K151545

CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System by Polymer Technology Systems, Inc. — Product Code CHH

K151545 is an FDA 510(k) premarket notification submitted by Polymer Technology Systems, Inc. for the device "CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System". The FDA issued a decision of Substantially Equivalent on December 22, 2016. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Polymer Technology Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2016
Date Received
June 9, 2015
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 Polymer Technology Systems, Inc.

  • K151530 — CardioChek Plus Test System (July 7, 2015)
  • K140068 — CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM (May 22, 2015)
  • K142302 — BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS (October 2, 2014)
  • K071593 — PTS PANELS CHOL+HDL PANEL TEST STRIPS (October 15, 2007)
  • K071507 — PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS (September 10, 2007)
  • K070017 — PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS (January 31, 2007)
  • K060617 — PTS PANELS HDL CHOLESTEROL TEST STRIPS (April 5, 2006)
  • K041750 — PTS PANELS CHOL+GLU TEST PANEL (July 23, 2004)
  • K040693 — PTS PANELS LDL CHOLESTEROL TEST STRIPS (July 6, 2004)
  • K023558 — PTS PANELS LIPID PANEL TEST STRIPS (November 15, 2002)

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)
  • K150654 — Cholesterol (September 29, 2015)
  • K132031 — AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL (March 21, 2014)
  • K130200 — PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM (February 15, 2013)

FDA data resources