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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Immunoglobulins (G, A, M)
510(k) Number K990553
Device Name IGM FLEX REAGENT CARTRIDGE
Applicant
Dade Behring, Inc.
P.O. Box 6101
Rte. 896, Glasgow Bldg. 500
Newark,  DE  19714
Applicant Contact CATHY P CRAFT
Correspondent
Dade Behring, Inc.
P.O. Box 6101
Rte. 896, Glasgow Bldg. 500
Newark,  DE  19714
Correspondent Contact CATHY P CRAFT
Regulation Number866.5510
Classification Product Code
CFQ  
Date Received02/22/1999
Decision Date 03/22/1999
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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