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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, luteinizing hormone
510(k) Number K902443
Device Name LUMATAG(TM) LH DIAGNOSTIC KIT
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 Number862.1485
Classification Product Code
CEP  
Date Received06/01/1990
Decision Date 08/02/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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