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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
510(k) Number K012163
Device Name POLYTITER SYSTEM
Applicant
Polymedco, Inc.
510 Furnace Dock Rd.
Cortlandt Manor,  NY  10567
Applicant Contact HELLEN LANDICHO
Correspondent
Polymedco, Inc.
510 Furnace Dock Rd.
Cortlandt Manor,  NY  10567
Correspondent Contact HELLEN LANDICHO
Regulation Number866.5100
Classification Product Code
DHN  
Date Received07/11/2001
Decision Date 08/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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