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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, Antigen, Control
510(k) Number K883883
Device Name ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS)
Applicant
Immco Diagnostics, Inc.
963 Kenmore Ave.
Buffalo,  NY  14223
Applicant Contact RUSSELL NISENGARD
Correspondent
Immco Diagnostics, Inc.
963 Kenmore Ave.
Buffalo,  NY  14223
Correspondent Contact RUSSELL NISENGARD
Regulation Number866.5100
Classification Product Code
LKJ  
Date Received09/13/1988
Decision Date 10/27/1988
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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