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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Occult Blood
510(k) Number K033548
Device Name ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
Applicant
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolos,  IN  46250
Applicant Contact JENNIFER TRIBBETT
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolos,  IN  46250
Correspondent Contact JENNIFER TRIBBETT
Regulation Number864.6550
Classification Product Code
KHE  
Subsequent Product Code
KQO  
Date Received11/12/2003
Decision Date 11/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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