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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Human Growth Hormone
510(k) Number K912858
Device Name LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY
Applicant
London Diagnostics, Inc.
10300 Valley View Rd.
Suite 107
Eden Prairie,  MN  55344
Applicant Contact RAMAKRISHNAN
Correspondent
London Diagnostics, Inc.
10300 Valley View Rd.
Suite 107
Eden Prairie,  MN  55344
Correspondent Contact RAMAKRISHNAN
Regulation Number862.1370
Classification Product Code
CFL  
Date Received06/28/1991
Decision Date 07/30/1991
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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