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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 (Enzyme-Labeled), Antigen, Controls
510(k) Number K943585
Device Name ANTI-HISTONE ANIBODY TEST
Applicant
Immco Diagnostics, Inc.
963 Kenmore Ave.
Buffalo,  NY  14223
Applicant Contact RICHARD E GRECO
Correspondent
Immco Diagnostics, Inc.
963 Kenmore Ave.
Buffalo,  NY  14223
Correspondent Contact RICHARD E GRECO
Regulation Number866.5100
Classification Product Code
LJM  
Date Received07/22/1994
Decision Date 01/20/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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