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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ferritin, Antigen, Antiserum, Control
510(k) Number K860137
Device Name ENZYMUN-TEST FERRITIN
Applicant
Boehringer Mannheim Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact SUE SMITH
Correspondent
Boehringer Mannheim Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact SUE SMITH
Regulation Number866.5340
Classification Product Code
DBF  
Date Received01/14/1986
Decision Date 03/28/1986
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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