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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Anticardiolipin Immunological
510(k) Number K914405
Device Name READS(R) IGA ANTI-CARDIOLIPIN TEST KIT
Applicant
Reads Medical Products, Inc.
Tejon St. Suite 120
Metro Tech Centre
Westminster,  CO  80234
Applicant Contact DEBRA SONGER
Correspondent
Reads Medical Products, Inc.
Tejon St. Suite 120
Metro Tech Centre
Westminster,  CO  80234
Correspondent Contact DEBRA SONGER
Regulation Number866.5660
Classification Product Code
MID  
Date Received10/02/1991
Decision Date 12/18/1991
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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