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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calibrator, multi-analyte mixture
510(k) Number K081103
Device Name LOCI THYROID CALIBRATOR WITH MODEL RC610
Applicant
Siemens Healthcare Diagnostics Inc.
PO BOX 6101
MAILBOX 514
NEWARK,  DE  19714 -6101
Applicant Contact YUK-TING LEWIS
Correspondent
Siemens Healthcare Diagnostics Inc.
PO BOX 6101
MAILBOX 514
NEWARK,  DE  19714 -6101
Correspondent Contact YUK-TING LEWIS
Regulation Number862.1150
Classification Product Code
JIX  
Date Received04/18/2008
Decision Date 05/23/2008
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
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