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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, testosterones and dihydrotestosterone
510(k) Number K151529
Device Name Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
500 GBC DR. P.O. BOX 6101 M/S 514
NEWARK,  DE  19714
Applicant Contact JULIE WARREN
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
500 GBC DR. P.O. BOX 6101 M/S 514
NEWARK,  DE  19714
Correspondent Contact JULIE WARREN
Regulation Number862.1680
Classification Product Code
CDZ  
Subsequent Product Code
JIT  
Date Received06/08/2015
Decision Date 02/11/2016
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
Recalls CDRH Recalls
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