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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name test system, antineutrophil cytoplasmic antibodies (anca)
510(k) Number K092601
Device Name IMMULISA ANCA SCREEN ELISA
Applicant
IMMCO DIAGNOSTICS, INC.
60 PINEVIEW DR.
BUFFALO,  NY  14228 -2120
Applicant Contact KEVIN LAWSON
Correspondent
IMMCO DIAGNOSTICS, INC.
60 PINEVIEW DR.
BUFFALO,  NY  14228 -2120
Correspondent Contact KEVIN LAWSON
Regulation Number866.5660
Classification Product Code
MOB  
Date Received08/24/2009
Decision Date 10/07/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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