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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 K881124
Device Name ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY
Applicant
Nichols Institute Diagnostics
P.O. Box 92797
Los Angeles,  CA  90009
Applicant Contact ELAINE WALTON
Correspondent
Nichols Institute Diagnostics
P.O. Box 92797
Los Angeles,  CA  90009
Correspondent Contact ELAINE WALTON
Regulation Number862.1485
Classification Product Code
CEP  
Date Received03/16/1988
Decision Date 04/18/1988
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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