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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Extractable Antinuclear Antibody, Antigen And Control
510(k) Number K901924
Device Name READS(R) ANTI-ENA (SM/RNP) TEST KIT
Applicant
Biosearch Medical Products, Inc.
5766 Central Ave.
Flatiron Industrial Park
Boulder,  CO  80301
Applicant Contact NANCY SAUER
Correspondent
Biosearch Medical Products, Inc.
5766 Central Ave.
Flatiron Industrial Park
Boulder,  CO  80301
Correspondent Contact NANCY SAUER
Regulation Number866.5100
Classification Product Code
LLL  
Date Received04/30/1990
Decision Date 05/09/1990
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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