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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K901484
Device Name LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC
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 Number862.1155
Classification Product Code
JHI  
Date Received03/29/1990
Decision Date 05/01/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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