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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Albumin, Antigen, Antiserum, Control
510(k) Number K113072
Device Name TINA-QUANT ALBUMIN GEN.2
Applicant
Roche Diagnostics Operations
9115 Hague Rd.
Indianpolis,  IN  46256
Applicant Contact PATRICK STIMART
Correspondent
Roche Diagnostics Operations
9115 Hague Rd.
Indianpolis,  IN  46256
Correspondent Contact PATRICK STIMART
Regulation Number866.5040
Classification Product Code
DCF  
Date Received10/17/2011
Decision Date 05/14/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Toxicology
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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