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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Rheumatoid Factor
510(k) Number K143736
Device Name ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA
Applicant
Immco Diagnostics, Inc.
9870 Hollingson Rd.
Clarence,  NY  14031
Applicant Contact Kevin Lawson
Correspondent
Immco Diagnostics, Inc.
9870 Hollingson Rd.
Clarence,  NY  14031
Correspondent Contact Kevin Lawson
Regulation Number866.5775
Classification Product Code
DHR  
Date Received12/30/2014
Decision Date 09/23/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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