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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alpha-1-Lipoprotein, Antigen, Antiserum, Control
510(k) Number K904125
Device Name UC IMU A
Applicant
Eucardio Laboratory, Inc.
9235 Trade Pl., Suite H
San Diego,  CA  92126
Applicant Contact WANG
Correspondent
Eucardio Laboratory, Inc.
9235 Trade Pl., Suite H
San Diego,  CA  92126
Correspondent Contact WANG
Regulation Number866.5580
Classification Product Code
DER  
Date Received09/06/1990
Decision Date 09/24/1990
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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