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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunochemical, Transferrin
510(k) Number K992188
Device Name NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODEL 62-7028
Applicant
Nichols Institute Diagnostics
33051 Calle Aviador
San Juan Capistrano,  CA  92675
Applicant Contact JAMES A RYBSKI
Correspondent
Nichols Institute Diagnostics
33051 Calle Aviador
San Juan Capistrano,  CA  92675
Correspondent Contact JAMES A RYBSKI
Regulation Number866.5880
Classification Product Code
JNM  
Date Received06/29/1999
Decision Date 12/06/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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