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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Test System NameRoche Diagnostics Cobas Integra 400  
Document NumberK951595
Parent Document NumberK951595
Analyte NameUrea (BUN)
Analyte SpecialtyGeneral Chemistry
ComplexityMODERATE
Effective Date10/25/1999
Device Classification Name Alkaline Picrate, Colorimetry, Creatinine
510(k) Number K951595
Device Name ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES
Applicant
Roche Diagnostic Systems, Inc.
Branchburg Township
1080 U.S. Hwy. 202
Somerville,  NJ  08876
Applicant Contact CAROL L KRIEGER
Correspondent
Roche Diagnostic Systems, Inc.
Branchburg Township
1080 U.S. Hwy. 202
Somerville,  NJ  08876
Correspondent Contact CAROL L KRIEGER
Regulation Number862.1225
Classification Product Code
CGX  
Subsequent Product Codes
CDQ   CDT   CEK   CEO   CET  
CFN   CFR   CGZ   CHH   CIC   CIG  
CIT   CIX   CJE   CKA   CZP   CZW  
DBI   DCN   DDG   DEL   DEW   DIC  
DIF   DIH   DIS   DJG   DJR   DKB  
DKZ   DLJ   DLZ   JFJ   JGJ   JGS  
JHN   JHS   JIX   JIY   JJE   JJY  
JQB   JXM   JXO   JZW   KHQ   KLI  
KXT   LAN   LAR   LAS   LBZ   LCM  
LCP   LDJ   LEG   LGI   LGQ   LGS  
LPT   MOJ  
Date Received04/06/1995
Decision Date 09/08/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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