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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 K901075
Device Name LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET.
Applicant
London Diagnostics, Inc.
10300 Valley View Rd.
Suite 107
Eden Prairie,  MN  55344
Applicant Contact RAMAKRISHNAN, PHD
Correspondent
London Diagnostics, Inc.
10300 Valley View Rd.
Suite 107
Eden Prairie,  MN  55344
Correspondent Contact RAMAKRISHNAN, PHD
Regulation Number866.5340
Classification Product Code
DBF  
Date Received03/08/1990
Decision Date 04/02/1990
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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