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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 K894579
Device Name CLEARPLAN EASY
Applicant
UNIPATH LTD.
NORSE ROAD
BEDFORD MK41 OQG,  GB
Applicant Contact GEORGE ZAJICEK
Correspondent
UNIPATH LTD.
NORSE ROAD
BEDFORD MK41 OQG,  GB
Correspondent Contact GEORGE ZAJICEK
Regulation Number862.1485
Classification Product Code
CEP  
Date Received07/24/1989
Decision Date 10/12/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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