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510(k) K041750

PTS PANELS CHOL+GLU TEST PANEL by Polymer Technology Systems, Inc. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2004
Date Received
June 29, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Blood Glucose, Over The Counter
Device Class
Class II
Regulation Number
862.1345
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)
  • K060617 — PTS PANELS HDL CHOLESTEROL TEST STRIPS (April 5, 2006)
  • K040693 — PTS PANELS LDL CHOLESTEROL TEST STRIPS (July 6, 2004)
  • K023558 — PTS PANELS LIPID PANEL TEST STRIPS (November 15, 2002)

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