Home / 510(k) Clearances / K211058

510(k) K211058

Lp(a) Ultra by SENTINEL CH. SpA — Product Code DFC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2022
Date Received
April 9, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lipoprotein, Low-Density, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5600
Review Panel
IM
Submission Type

Other clearances by SENTINEL CH. SpA

  • K242585 — Cystatin C (May 16, 2025)
  • K193001 — Albumin BCP (December 19, 2019)
  • K192118 — CRP Vario (November 8, 2019)
  • K173833 — CRP Vario (September 27, 2018)
  • K141728 — ACE CALIBRATOR (July 28, 2014)
  • K102706 — CKMB UDR ASSAY (August 19, 2011)
  • K083602 — KAPPA LIGHT CHAINS (September 3, 2009)
  • K083601 — LAMBDA LIGHT CHAINS (June 22, 2009)
  • K081533 — SENTINEL PLASMAPROTEINS CAL 3X (June 25, 2008)
  • K073634 — MULTIGENT CREATININE (ENZYMATIC) ASSAY (June 19, 2008)

Other clearances for product code DFC

  • K241220 — Tina-quant Lipoprotein(a) Gen.2 Molarity (January 24, 2025)
  • K180074 — Diazyme Lipoprotein (a) Assay (March 22, 2018)
  • K123046 — ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR (December 20, 2012)
  • K122722 — COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A (November 29, 2012)
  • K082488 — DIAZYME LP(A) ASSAY (January 13, 2009)
  • K063838 — LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH (September 27, 2007)
  • K050487 — QUANTIA LA(A) (April 26, 2005)
  • K023853 — K-ASSAY LP(A) CONTROLS (December 13, 2002)
  • K021660 — K-ASSAY LP(A) ASSAY (July 25, 2002)
  • K013359 — LP(A)-LATEX SEIKEN ASSAY KIT (March 8, 2002)