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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Igm (Mu Chain Specific), Antigen, Antiserum, Control
510(k) Number K955908
Device Name BOEHRINGER MANNHEIM IGM ASSAY
Applicant
BOEHRINGER MANNHEIM CORP.
9115 HAGUE RD.
P.O. BOX 50457
INDIANAPOLIS,  IN  46250 -0457
Applicant Contact JOHN D STEVENS
Correspondent
BOEHRINGER MANNHEIM CORP.
9115 HAGUE RD.
P.O. BOX 50457
INDIANAPOLIS,  IN  46250 -0457
Correspondent Contact JOHN D STEVENS
Regulation Number866.5550
Classification Product Code
DAO  
Date Received12/29/1995
Decision Date 02/09/1996
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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