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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Human Chorionic Gonadotropin
510(k) Number K891096
Device Name VIS-DISK HCG (EIA) JPL-041M
Applicant
LEECO DIAGNOSTICS, INC.
21705 EVERGREEN
P.O. BOX 5126
SOUTHFIELD,  MI  48075
Applicant Contact CAPALDI PHD
Correspondent
LEECO DIAGNOSTICS, INC.
21705 EVERGREEN
P.O. BOX 5126
SOUTHFIELD,  MI  48075
Correspondent Contact CAPALDI PHD
Regulation Number862.1155
Classification Product Code
DHA  
Date Received03/02/1989
Decision Date 06/16/1989
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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