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510(k) K060617

PTS PANELS HDL CHOLESTEROL TEST STRIPS by Polymer Technology Systems, Inc. — Product Code NAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2006
Date Received
March 8, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lipoprotein, High Density, Hdl, Over The Counter
Device Class
Class I
Regulation Number
862.1175
Review Panel
CH
Submission Type

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  • 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)
  • 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 NAQ

  • K993377 — MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC) (January 13, 2000)