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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 K901230
Device Name REAADS ANTI-SM TEST KIT
Applicant
Biosearch Medical Products, Inc.
Suite 1203 Crystal Plz. Bldg1
2001 Jefferson Davis, Box 2286
Arlington,  VA  22202
Applicant Contact JERRY BERKSTRESSER
Correspondent
Biosearch Medical Products, Inc.
Suite 1203 Crystal Plz. Bldg1
2001 Jefferson Davis, Box 2286
Arlington,  VA  22202
Correspondent Contact JERRY BERKSTRESSER
Regulation Number866.5100
Classification Product Code
LLL  
Date Received03/14/1990
Decision Date 03/23/1990
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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