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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K121084
Device Name LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L
Applicant
Siemens Healthcare Diagnostics, Inc.
P.O. Box 6101
Mailstop 514
Newark,  DE  19714 -6101
Applicant Contact FRANCES A DILLON
Correspondent
Siemens Healthcare Diagnostics, Inc.
P.O. Box 6101
Mailstop 514
Newark,  DE  19714 -6101
Correspondent Contact FRANCES A DILLON
Regulation Number862.1660
Classification Product Code
JJX  
Date Received04/10/2012
Decision Date 05/09/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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