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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Vitamin D
510(k) Number K113546
Device Name ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250 -0416
Applicant Contact Michael Leuther
Correspondent
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250 -0416
Correspondent Contact Michael Leuther
Regulation Number862.1825
Classification Product Code
MRG  
Subsequent Product Codes
JIT   JJX   JJY  
Date Received12/01/2011
Decision Date 07/24/2012
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
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