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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 K952287
Device Name REAADS ANTI-PHOSPHATIDYLSERINE QUANTITATIVE TEST KIT
Applicant
Reaads Medical Products, Inc.
12001 Tejon St.
Suite 120
Westminister,  CO  80234
Applicant Contact JACK ROGERS
Correspondent
Reaads Medical Products, Inc.
12001 Tejon St.
Suite 120
Westminister,  CO  80234
Correspondent Contact JACK ROGERS
Regulation Number866.5660
Classification Product Code
MID  
Date Received05/16/1995
Decision Date 12/18/1995
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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