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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 (Enzyme-Labeled), Antigen, Controls
510(k) Number K896347
Device Name IMMUNODOT AUTOIMMUNE SCREENING PANEL 1
Applicant
General Biometrics, Inc.
15222 Ave. Of Science
Suite A
San Diego,  CA  92128
Applicant Contact KIEHL, PHD
Correspondent
General Biometrics, Inc.
15222 Ave. Of Science
Suite A
San Diego,  CA  92128
Correspondent Contact KIEHL, PHD
Regulation Number866.5100
Classification Product Code
LJM  
Date Received11/03/1989
Decision Date 12/05/1989
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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