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510(k) K083602

KAPPA LIGHT CHAINS by SENTINEL CH. SpA — Product Code DFH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2009
Date Received
December 5, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kappa, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5550
Review Panel
IM
Submission Type

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  • K141728 — ACE CALIBRATOR (July 28, 2014)
  • K102706 — CKMB UDR ASSAY (August 19, 2011)
  • K083601 — LAMBDA LIGHT CHAINS (June 22, 2009)
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  • K073634 — MULTIGENT CREATININE (ENZYMATIC) ASSAY (June 19, 2008)

Other clearances for product code DFH

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  • K231601 — FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 (February 23, 2024)
  • K231290 — Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit (January 24, 2024)
  • K210623 — FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 (November 18, 2022)
  • K211648 — Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chai (September 8, 2022)
  • K220001 — Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chai (August 4, 2022)
  • K212379 — N Latex FLC kappa, N Latex FLC lambda (March 2, 2022)
  • K201496 — N Latex FLC kappa, N Latex FLC lambda (October 29, 2021)
  • K193047 — N Latex FLC kappa, N Latex FLC lambda (July 14, 2021)