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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Dna Indirect Immunofluorescent Solid Phase
510(k) Number K013432
Device Name IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G
Applicant
Immuno Concepts, Inc.
9779 Business Park Dr.
Suite D
Sacramento,  CA  95827
Applicant Contact ERIC S HOY
Correspondent
Immuno Concepts, Inc.
9779 Business Park Dr.
Suite D
Sacramento,  CA  95827
Correspondent Contact ERIC S HOY
Regulation Number866.5100
Classification Product Code
KTL  
Date Received10/15/2001
Decision Date 11/29/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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