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510(k) K091741

TINA-QUANT CERULOPLASMIN by Roche Diagnostics — Product Code CHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2010
Date Received
June 16, 2009
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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