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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, test, blood glucose, over the counter
510(k) Number K071507
Device Name PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS
Original Applicant
POLYMER TECHNOLOGY SYSTEMS, INC.
7736 zionsville rd.
indianapolis,  IN  46268
Original Contact margo enright
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   CHH   LBR  
Date Received06/01/2007
Decision Date 09/10/2007
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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