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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion Specific, Sodium
510(k) Number K151767
Device Name Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
500 GBC DRIVE
PO BOX 6101 MS 514
NEWARK,  DE  19711
Applicant Contact Laura J. Duggan
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
500 GBC DRIVE, M/S 514
PO BOX 6101
NEWARK,  DE  19714 -6101
Correspondent Contact Laura J. Duggan
Regulation Number862.1665
Classification Product Code
JGS  
Subsequent Product Codes
CEM   CGZ   CJW   JIT   JIX  
JJE  
Date Received06/30/2015
Decision Date 12/11/2015
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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