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510(k) K142302

BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System by Polymer Technology Systems, Inc. — Product Code CGA

K142302 is an FDA 510(k) premarket notification submitted by Polymer Technology Systems, Inc. for the device "BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System". The FDA issued a decision of Substantially Equivalent on October 2, 2014. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Polymer Technology Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2014
Date Received
August 18, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose Oxidase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Polymer Technology Systems, Inc.

  • K151545 — CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test Sys (December 22, 2016)
  • K151530 — CardioChek Plus Test System (July 7, 2015)
  • K140068 — CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM (May 22, 2015)
  • 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 CGA

  • K252488 — ABL90 FLEX PLUS System (May 1, 2026)
  • K210933 — YSI 2900C Biochemistry Analyzer (September 30, 2024)
  • K220328 — EasyStat 300 (July 26, 2024)
  • K223179 — Cholestech LDX ™ System (September 20, 2023)
  • K223755 — i-STAT G cartridge with the i-STAT 1 System (September 11, 2023)
  • K223710 — i-STAT CG8+ cartridge with the i-STAT 1 System (July 28, 2023)
  • K223090 — GEM Premier ChemSTAT (January 27, 2023)
  • K203549 — Nova Primary Glucose Analyzer System (October 18, 2022)
  • K210958 — i-STAT CHEM8+ cartridge with the i-STAT 1 System (August 13, 2021)
  • K200349 — Stat Profile Prime Plus Analyzer System (March 13, 2020)

FDA data resources