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510(k) K882622

CERULOPLASMIN FOR THE TECHNICON DPA-1(TM) SYSTEM by Technicon Instruments Corp. — Product Code JFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1988
Date Received
June 24, 1988
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

  • K051456 — SENTINEL CERULOPLASMIN (October 21, 2005)