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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name turbidimetric, total protein
510(k) Number K071239
Device Name TOTAL PROTEIN URINE/CSF GEN.3
Applicant
Roche Diagnostics
9155 HAGUE RD.
PO BOX 50416
INDIANAPOLIS,  IN  46250
Applicant Contact CORINA HARPER
Correspondent
Roche Diagnostics
9155 HAGUE RD.
PO BOX 50416
INDIANAPOLIS,  IN  46250
Correspondent Contact CORINA HARPER
Regulation Number862.1635
Classification Product Code
JGQ  
Subsequent Product Code
JIX  
Date Received05/03/2007
Decision Date 09/14/2007
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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