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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, low density, lipoprotein
510(k) Number K040693
Device Name PTS PANELS LDL CHOLESTEROL TEST STRIPS
Applicant
POLYMER TECHNOLOGY SYSTEMS, INC.
7736 ZIONSVILLE RD.
INDIANAPOLIS,  IN  46268
Applicant Contact MARGO ENRIGHT
Correspondent
POLYMER TECHNOLOGY SYSTEMS, INC.
7736 ZIONSVILLE RD.
INDIANAPOLIS,  IN  46268
Correspondent Contact MARGO ENRIGHT
Regulation Number862.1475
Classification Product Code
MRR  
Date Received03/17/2004
Decision Date 07/06/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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