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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, luteinizing hormone
510(k) Number K861354
Device Name RIGHT-DAY OVULATION HOME TEST
Applicant
LEECO DIAGNOSTICS, INC.
21705 EVERGREEN
P.O. BOX 5126
SOUTHFIELD,  MI  48075
Applicant Contact LEE, PH.D.
Correspondent
LEECO DIAGNOSTICS, INC.
21705 EVERGREEN
P.O. BOX 5126
SOUTHFIELD,  MI  48075
Correspondent Contact LEE, PH.D.
Regulation Number862.1485
Classification Product Code
CEP  
Date Received04/10/1986
Decision Date 09/16/1986
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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