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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetric Method, Triglycerides
510(k) Number K991894
Device Name BIOSCANNER TRIGLYCERIDES 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 Number862.1705
Classification Product Code
JGY  
Date Received06/03/1999
Decision Date 05/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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