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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 K792350
Device Name CENTRIA LH RIA
Applicant
Union Carbide Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Union Carbide Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1485
Classification Product Code
CEP  
Date Received11/19/1979
Decision Date 01/16/1980
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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