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510(k) K040693

PTS PANELS LDL CHOLESTEROL TEST STRIPS by Polymer Technology Systems, Inc. — Product Code MRR

K040693 is an FDA 510(k) premarket notification submitted by Polymer Technology Systems, Inc. for the device "PTS PANELS LDL CHOLESTEROL TEST STRIPS". The FDA issued a decision of Substantially Equivalent on July 6, 2004. The device falls under product code MRR (System, Test, Low Density, Lipoprotein), a Class I device regulated under 21 CFR 862.1475. Polymer Technology Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2004
Date Received
March 17, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Low Density, Lipoprotein
Device Class
Class I
Regulation Number
862.1475
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)
  • 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)
  • K023558 — PTS PANELS LIPID PANEL TEST STRIPS (November 15, 2002)

Other clearances for product code MRR

  • K241800 — Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) (July 26, 2024)
  • K210801 — AXINON® LDL-p Test System (July 19, 2023)
  • K161691 — Direct LDL Cholesterol (LDL) (March 20, 2017)
  • K091333 — S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 (August 3, 2009)
  • K090734 — EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROL (July 17, 2009)
  • K063841 — NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS (July 23, 2008)
  • K051121 — DIRECT LDL CHOLESTEROL, MODEL L530-60H (August 8, 2005)
  • K043264 — LDL-EX SEIKEN ASSAY KIT (January 26, 2005)
  • K041927 — LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 (November 23, 2004)
  • K041720 — VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND P (August 25, 2004)

FDA data resources