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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 K172745
Device Name ImmuGlo HEp-2 Elite IFA
Applicant
Immco Diagnostics, Inc.
60 Pineview Dr.
Buffalo,  NY  14228
Applicant Contact Kevin Lawson
Correspondent
Immco Diagnostics, Inc.
60 Pineview Dr.
Buffalo,  NY  14228
Correspondent Contact Kevin Lawson
Regulation Number866.5100
Classification Product Code
DHN  
Date Received09/12/2017
Decision Date 06/05/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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