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510(k) K051456

SENTINEL CERULOPLASMIN by Sentinel Ch. Srl — Product Code JFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2005
Date Received
June 2, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indirect Copper Assay, Ceruloplasmin
Device Class
Class II
Regulation Number
866.5210
Review Panel
IM
Submission Type

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Other clearances for product code JFR

  • K882622 — CERULOPLASMIN FOR THE TECHNICON DPA-1(TM) SYSTEM (July 8, 1988)