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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Myoglobin, Antigen, Antiserum, Control
510(k) Number K904038
Device Name MYOGLOBIN RIA TEST KIT
Applicant
Immuno Diagnostic Center, Inc.
607 S. Friendswood
Suite 27
Friendswood,  TX  77546
Applicant Contact AMAL MUKHERJEE
Correspondent
Immuno Diagnostic Center, Inc.
607 S. Friendswood
Suite 27
Friendswood,  TX  77546
Correspondent Contact AMAL MUKHERJEE
Regulation Number866.5680
Classification Product Code
DDR  
Date Received09/04/1990
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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