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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.
Indianapolis,  IN  46250
Applicant Contact ANGELO PEREIRA
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact ANGELO PEREIRA
Regulation Number866.5040
Classification Product Code
DCF  
Subsequent Product Codes
KNK   KXS   KXT   LAN   LAR  
LBS   LBZ   LCM   LCP   LDJ   LDP  
LEG   LEH   MRR   NDW   NDY   NQD  
OAV   KLB   KLP   KLS   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  
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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