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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, Antigen, Control
510(k) Number K932679
Device Name RHEUMELISA II HISTONE ANTIBODY TEST KIT
Applicant
Biowhittaker Molecular Applications, Inc.
8830 Biggs Ford Rd.
Walkersville,  MD  21793 -0127
Applicant Contact LEIF E OLSEN
Correspondent
Biowhittaker Molecular Applications, Inc.
8830 Biggs Ford Rd.
Walkersville,  MD  21793 -0127
Correspondent Contact LEIF E OLSEN
Regulation Number866.5100
Classification Product Code
LKJ  
Date Received06/02/1993
Decision Date 08/23/1993
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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