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510(k) K040693

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

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

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  • K041750 — PTS PANELS CHOL+GLU TEST PANEL (July 23, 2004)
  • K023558 — PTS PANELS LIPID PANEL TEST STRIPS (November 15, 2002)

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