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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 K100853
Device Name COBAS 8000 MODULAR SERIES ANALYZER
Applicant
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolos,  IN  46250
Applicant Contact ANGELO PEREIRA
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolos,  IN  46250
Correspondent Contact ANGELO PEREIRA
Regulation Number866.5040
Classification Product Code
DCF  
Subsequent Product Codes
CDQ   CDT   CEM   CEO   CFJ  
CFR   CGX   CGZ   CHH   CHN   CIC  
CIG   CIT   CIX   CJE   CJW   CJX  
CZP   CZW   DAD   DAO   DBF   DBI  
DCN   DDG   DDR   DEM   DER   DFC  
DHR   DIH   DIO   DIP   DIS   DJG  
DJR   DKJ   DKZ   DLB   DLZ   DML  
GHH   JFJ   JGJ   JGQ   JGS   JHS  
JIF   JIY   JJE   JMO   JXM   JXN  
JZG   KHP   KHS   KLB   KLP   KLS  
KNK   KXS   KXT   LAN   LAR   LBS  
LBZ   LCM   LCP   LDJ   LDP   LEG  
LEH   MRR   NDW   NDY   NQD   OAV  
Date Received03/26/2010
Decision Date 09/09/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
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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