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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, free thyroxine
510(k) Number K140842
Device Name DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART
Applicant
Siemens Healthcare Diagnostics Inc.
PO BOX 6101
M/S 514
NEWARK,  DE  19714 -6101
Applicant Contact FRANCES A DILLON
Correspondent
Siemens Healthcare Diagnostics Inc.
PO BOX 6101
M/S 514
NEWARK,  DE  19714 -6101
Correspondent Contact FRANCES A DILLON
Regulation Number862.1695
Classification Product Code
CEC  
Subsequent Product Code
JLW  
Date Received04/02/2014
Decision Date 11/26/2014
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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