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510(k) K062114

CERULOPLASMIN, MODEL 2055953 by Roche Diagnostics Corp. — Product Code CHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2007
Date Received
July 24, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunochemical, Ceruloplasmin
Device Class
Class II
Regulation Number
866.5210
Review Panel
IM
Submission Type

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