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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calibrator, secondary
510(k) Number K081683
Device Name LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
MS 514, PO BOX 6101
NEWARK,  DE  19714 -6101
Applicant Contact YUK-TING LEWIS
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
MS 514, PO BOX 6101
NEWARK,  DE  19714 -6101
Correspondent Contact YUK-TING LEWIS
Regulation Number862.1150
Classification Product Code
JIT  
Date Received06/17/2008
Decision Date 07/07/2008
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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