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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 K964165
Device Name MICRO21 WITH NDNA
Applicant
Triangle Biomedical Sciences, Inc.
4360 Northlake Blvd.
Suite 214
Palm Beach Gardens,  FL  33410
Applicant Contact R. OTTO STELLNER
Correspondent
Triangle Biomedical Sciences, Inc.
4360 Northlake Blvd.
Suite 214
Palm Beach Gardens,  FL  33410
Correspondent Contact R. OTTO STELLNER
Regulation Number866.5100
Classification Product Code
DHN  
Date Received10/17/1996
Decision Date 01/03/1997
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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