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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 K162840
Device Name Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianapolos,  IN  46250
Applicant Contact Linda McCammack
Correspondent
Roche Diagnostics
9115 Hague Rd.
Indianapolos,  IN  46250
Correspondent Contact Linda McCammack
Regulation Number862.1825
Classification Product Code
MRG  
Subsequent Product Codes
JIT   JJX  
Date Received10/11/2016
Decision Date 02/08/2017
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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