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510(k) K993377

MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC) by Polymer Technology Systems, Inc. — Product Code NAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2000
Date Received
September 28, 1999
Clearance Type
Traditional
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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Other clearances for product code NAQ

  • K060617 — PTS PANELS HDL CHOLESTEROL TEST STRIPS (April 5, 2006)