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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK041750
Test Name Polymer Technology Systems CardioChek PA Analyzer  {PTS PANELS CHOL+GLU TEST PANEL} 
Manufacturer NamePOLYMER TECHNOLOGY SYSTEMS, INC.
Consumer Information Phone NumberNO PHONE NUMBER
Test TypeCholesterol
Effective Date02/15/2005
Device Classification Name system, test, blood glucose, over the counter
510(k) Number K041750
Device Name PTS PANELS CHOL+GLU TEST PANEL
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 Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   CHH  
Date Received06/29/2004
Decision Date 07/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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