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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Sm Antibody, Antigen And Control
510(k) Number K911851
Device Name IMMUNOWELL SM ANTIBODY TEST
Applicant
General Biometrics, Inc.
15222 Ave. Of Science
Suite A
San Diego,  CA  92128
Applicant Contact BRYAN L.KIEHL,PH.D.
Correspondent
General Biometrics, Inc.
15222 Ave. Of Science
Suite A
San Diego,  CA  92128
Correspondent Contact BRYAN L.KIEHL,PH.D.
Regulation Number866.5100
Classification Product Code
LKP  
Date Received04/26/1991
Decision Date 05/07/1991
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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