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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 K990688
Device Name MTM BIOSCANNER C 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  
Date Received02/25/1999
Decision Date 06/24/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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