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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Human Growth Hormone
510(k) Number K955390
Device Name INSULIN-LIKE GROWTH FACTOR-I (IGF-I) IMMUNORADIOMETRIC ASSAY
Applicant
Corning Nichols Diagnostics
33061 Calle Aviador
San Juan Capistrano,  CA  92675
Applicant Contact DAVE D SMITH
Correspondent
Corning Nichols Diagnostics
33061 Calle Aviador
San Juan Capistrano,  CA  92675
Correspondent Contact DAVE D SMITH
Regulation Number862.1370
Classification Product Code
CFL  
Date Received11/24/1995
Decision Date 12/29/1995
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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