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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Follicle-Stimulating Hormone
510(k) Number K905814
Device Name LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY
Applicant
London Diagnostics, Inc.
10300 Valley View Rd.
Suite 107
Eden Prairie,  MN  55344
Applicant Contact BEHESHTI, PH.D.
Correspondent
London Diagnostics, Inc.
10300 Valley View Rd.
Suite 107
Eden Prairie,  MN  55344
Correspondent Contact BEHESHTI, PH.D.
Regulation Number862.1300
Classification Product Code
CGJ  
Date Received12/28/1990
Decision Date 02/04/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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