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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Time, Partial Thromboplastin
510(k) Number K902236
Device Name READS ANTI-CARDIOLIPIN SEMI-QUANTITATIVE 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 Number864.7925
Classification Product Code
GGW  
Date Received05/17/1990
Decision Date 08/14/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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