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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 K101460
Device Name LOCI 8 CALIBRATOR, MODEL KC 646
Applicant
Siemens Healthcare Diagnostics
500 Gbc Dr.
P.O. Box 6101
Newark,  DE  19714 -6101
Applicant Contact ANNA MARIE ENNIS
Correspondent
Siemens Healthcare Diagnostics
500 Gbc Dr.
P.O. Box 6101
Newark,  DE  19714 -6101
Correspondent Contact ANNA MARIE ENNIS
Regulation Number862.1150
Classification Product Code
JIX  
Date Received05/26/2010
Decision Date 07/09/2010
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
Recalls CDRH Recalls
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