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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name turbidimetric method, protein or albumin (urinary, non-quant.)
510(k) Number K141925
Device Name TOTAL PROTEIN URINE/CSF GEN.3
Applicant
Roche Diagnostics Operations (RDO)
9115 Hague Road
Indianapolis,  IN  46250
Applicant Contact PATRICK STIMART
Correspondent
Roche Diagnostics Operations (RDO)
9115 Hague Road
Indianapolis,  IN  46250
Correspondent Contact PATRICK STIMART
Regulation Number862.1645
Classification Product Code
JIQ  
Date Received07/16/2014
Decision Date 12/09/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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