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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
Original Applicant
ROCHE DIAGNOSTICS OPERATIONS
9115 hague rd
indianapolis,  IN  46256
Original 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
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