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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 K810662
Device Name LEECO LH-QUANT DIAGNOSTIC KIT
Applicant
LEECO DIAGNOSTICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
LEECO DIAGNOSTICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1485
Classification Product Code
CEP  
Date Received03/11/1981
Decision Date 03/31/1981
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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