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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
510(k) Number K101319
Device Name IMMULISA DSDNA ANTIBODY ELISA
Applicant
Immco Diagnostics, Inc.
60 Pineview Dr.
Buffalo,  NY  14228
Applicant Contact KEVIN LAWSON
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number866.5100
Classification Product Code
LRM  
Date Received05/11/2010
Decision Date 12/09/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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