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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 K902154
Device Name NA LATEX MYOGLOBIN TEST
Applicant
BEHRING DIAGNOSTICS, INC.
17 CHUBB WAY
SOMERVILLE,  NJ  08876
Applicant Contact JOHN E HUGHES
Correspondent
BEHRING DIAGNOSTICS, INC.
17 CHUBB WAY
SOMERVILLE,  NJ  08876
Correspondent Contact JOHN E HUGHES
Regulation Number866.5680
Classification Product Code
DDR  
Date Received05/15/1990
Decision Date 06/01/1990
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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