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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 K942052
Device Name LIFESIGN MI MYOGLOBIN
Applicant
Princeton Biomedix
P.O. Box 7139
Princeton,  NJ  08543
Applicant Contact JEMO KANG,PH.D
Correspondent
Princeton Biomedix
P.O. Box 7139
Princeton,  NJ  08543
Correspondent Contact JEMO KANG,PH.D
Regulation Number866.5680
Classification Product Code
DDR  
Date Received04/28/1994
Decision Date 02/07/1995
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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