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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 K842991
Device Name AUTOFLUOR V SYSTEM
Applicant
Tech America Diagnostics
348-A Rancheros Dr.
San Marcos,  CA  92069
Applicant Contact JUDITH A GAWARECKI
Correspondent
Tech America Diagnostics
348-A Rancheros Dr.
San Marcos,  CA  92069
Correspondent Contact JUDITH A GAWARECKI
Regulation Number866.5100
Classification Product Code
DHN  
Date Received07/30/1984
Decision Date 03/14/1985
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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