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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K880069
Device Name LEECO PREGNASTICK (EIA) CATALOG #003
Applicant
Leeco Diagnostics, Inc.
21705 Evergreen
P.O. Box 5126
Southfield,  MI  48075
Applicant Contact LEE, PHD
Correspondent
Leeco Diagnostics, Inc.
21705 Evergreen
P.O. Box 5126
Southfield,  MI  48075
Correspondent Contact LEE, PHD
Regulation Number862.1155
Classification Product Code
LCX  
Date Received01/11/1988
Decision Date 02/11/1988
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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