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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoassay Method, Troponin Subunit
510(k) Number K081643
Device Name DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692
Applicant
Siemens Healthcare Diagnostics
Ms 514, P.O. Box 6101
Newark,  DE  19714 -6101
Applicant Contact YUK-TING LEWIS
Correspondent
Siemens Healthcare Diagnostics
Ms 514, P.O. Box 6101
Newark,  DE  19714 -6101
Correspondent Contact YUK-TING LEWIS
Regulation Number862.1215
Classification Product Code
MMI  
Date Received06/12/2008
Decision Date 07/03/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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