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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 K923195
Device Name MYOGLOBIN ELISA TEST KIT
Applicant
Immuno Diagnostic Center, Inc.
9978 Monroe Dr., Suite 303
Dallas,  TX  75220
Applicant Contact AMAL MUKHERJEE
Correspondent
Immuno Diagnostic Center, Inc.
9978 Monroe Dr., Suite 303
Dallas,  TX  75220
Correspondent Contact AMAL MUKHERJEE
Regulation Number866.5680
Classification Product Code
DDR  
Date Received06/30/1992
Decision Date 11/06/1992
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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