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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunochemical, Ceruloplasmin
510(k) Number K091741
Device Name TINA-QUANT CERULOPLASMIN
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact KATHIE J GOODWIN
Correspondent
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact KATHIE J GOODWIN
Regulation Number866.5210
Classification Product Code
CHN  
Date Received06/16/2009
Decision Date 03/18/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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