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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, testosterones and dihydrotestosterone
510(k) Number K860003
Device Name LEECO TESTOSTERONE DIAGNOSTIC KIT
Applicant
LEECO DIAGNOSTICS, INC.
21705 EVERGREEN
P.O. BOX 5126
SOUTHFIELD,  MI  48075
Applicant Contact JAMES P LEE
Correspondent
LEECO DIAGNOSTICS, INC.
21705 EVERGREEN
P.O. BOX 5126
SOUTHFIELD,  MI  48075
Correspondent Contact JAMES P LEE
Regulation Number862.1680
Classification Product Code
CDZ  
Date Received01/02/1986
Decision Date 03/17/1986
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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