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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Esterase--Oxidase, Cholesterol
510(k) Number K022898
Device Name PTS PANELS LIPID PANEL 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 Number862.1175
Classification Product Code
CHH  
Subsequent Product Codes
JGY   LBR  
Date Received09/03/2002
Decision Date 09/24/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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