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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry, Micro, For Clinical Use
510(k) Number K033734
Device Name LIGHTCYCLER INSTRUMENT VERSION 1.2
Applicant
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact ROBERT A GREGG
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact ROBERT A GREGG
Regulation Number862.2170
Classification Product Code
JJF  
Date Received11/28/2003
Decision Date 12/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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