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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 K984191
Device Name MYOGLOBIN FLEX REAGENT CARTRIDGE
Applicant
Dade Behring, Inc.
P.O. Box 6101
Glasgow Bldg. 500
Newark,  DE  19714 -6101
Applicant Contact REBECCA S AYASH
Correspondent
Dade Behring, Inc.
P.O. Box 6101
Glasgow Bldg. 500
Newark,  DE  19714 -6101
Correspondent Contact REBECCA S AYASH
Regulation Number866.5680
Classification Product Code
DDR  
Date Received11/23/1998
Decision Date 12/10/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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