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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay (Two-Site Solid Phase), Ferritin
510(k) Number K971833
Device Name ELECSYS FERRITIN
Applicant
Boehringer Mannheim Corp.
9115 Hague Rd., P.O. Box 50457
Indianapolis,  IN  46250 -0457
Applicant Contact LEEANN CHAMBERS
Correspondent
Boehringer Mannheim Corp.
9115 Hague Rd., P.O. Box 50457
Indianapolis,  IN  46250 -0457
Correspondent Contact LEEANN CHAMBERS
Regulation Number866.5340
Classification Product Code
JMG  
Date Received05/19/1997
Decision Date 06/02/1997
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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